<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01674530</url>
  </required_header>
  <id_info>
    <org_study_id>DRL-USG01-L/2012</org_study_id>
    <nct_id>NCT01674530</nct_id>
  </id_info>
  <brief_title>Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation</brief_title>
  <official_title>A,Randomized , Double-blind,Double -Dummy Placebo-controlled,Parallel -Group, Multicenter Study to Evaluate the Clinical Equivalence of Lubiprostone 24 mcg Capsules ( Dr. Reddy's Laboratories Ltd.) With AMITIZA® (Lubiprostone ) 24 mcg Capsules ( Sucampo Pharmaceuticals, Inc. ) in the Treatment of Chronic Idiopathic Constipation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Reddy's Laboratories Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Parexel</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Dr. Reddy's Laboratories Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the clinical equivalence and safety of the test&#xD;
      formulation of Lubiprostone 24 mcg capsules manufactured by Dr Reddy's Laboratories Ltd&#xD;
      compared to the marketed formulation AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo&#xD;
      Pharmaceuticals, Inc.) in patients with confirmed Chronic Idiopathic Constipation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Constipation is a common gastrointestinal problem estimated to effect 2-27 % of the&#xD;
      population in United States . It is found more commonly in women and elderly . The prevelance&#xD;
      of constipation and growing demand for treatment dictate the need for safe and effective&#xD;
      treatment options . Lubiprostone is the first chloride channel activator approved by FDA for&#xD;
      long term treatment of chronic idiopathic constipation in adult men and women . To provide a&#xD;
      generic medicine to the U.S population Dr Reddy's Laboratories intends to conduct this study&#xD;
      to evaluate that the Lubiprostone manufactured by it is equally effective and safe as&#xD;
      marketed AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Analysis</measure>
    <time_frame>Day 8</time_frame>
    <description>Clinical equivalence of the Test and Reference treatments and the superiority of each active treatment over the Placebo in the change from baseline in mean number of SBM's during the 7 day treatment period of the study</description>
  </primary_outcome>
  <other_outcome>
    <measure>Safety Analysis</measure>
    <time_frame>Day 8</time_frame>
    <description>The type , frequency and severity of adverse events across the treatment groups will be analyzed at the end of the study</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">909</enrollment>
  <condition>Chronic Idiopathic Constipation</condition>
  <arm_group>
    <arm_group_label>Lubiprostone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Manufactured by Dr Reddy's Laboratories Ltd( 24 mcg administered for 7 days )</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AMITIZA®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Manufactured by Sucampo Pharmaceuticals(24 mcg administered for 7 days)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Manufactured by Dr Reddy's Laboratories Ltd ( 24 mcg adminstered for 7 days )</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lubiprostone</intervention_name>
    <description>24 mcg Capsules to be given in the experimental arm with Placebo Of AMITIZA</description>
    <arm_group_label>Lubiprostone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lubiprostone</intervention_name>
    <description>24 mcg Capsules with placebo of Lubiprostone ( Manufactured by Dr Reddy's Laboratories Ltd)</description>
    <arm_group_label>AMITIZA®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>24 mcg capsules of both experimental Lubiprostone and AMITIZA</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          1. Patients who have signed the written informed consent form prior to entering the&#xD;
             study.&#xD;
&#xD;
          2. Male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of CIC defined&#xD;
             as, on average, &lt; 3 SBMs per week and confirmed by daily diary during the two week&#xD;
             baseline/washout period. An SBM is defined as any bowel movement (BM) that does not&#xD;
             occur within 24 hours after rescue medication use.&#xD;
&#xD;
          3. Patients with body mass index between 18 and 35kg/m2 (both inclusive)&#xD;
&#xD;
          4. Have one or more of the following symptoms related to BMs for at least 6 months before&#xD;
             the baseline visit and confirmed by daily diary during the 2 weeks baseline/washout&#xD;
             period:&#xD;
&#xD;
             i. very hard (little balls) and/or hard stools for at least 25% of the bowel movements&#xD;
             ii. sensation of incomplete evacuation following at least 25% of the bowel movements&#xD;
             iii. straining at defecation at least a quarter of the time&#xD;
&#xD;
          5. Women of child-bearing potential should have a negative serum pregnancy test prior to&#xD;
             beginning therapy and agree to use effective contraceptive methods (at least one&#xD;
             medically approved and highly effective method of birth control defined as those which&#xD;
             result in a low failure rate (i.e., less than 1% per year) when used consistently and&#xD;
             correctly such as implants, injectables, oral contraceptives combined with at least&#xD;
             one barrier method, hormonal IUDs, sexual abstinence or vasectomy of the partner)&#xD;
             during the study.&#xD;
&#xD;
          6. For patients aged &lt; 50 years, documentation of the results of either a flexible&#xD;
             sigmoidoscopy or colonoscopy performed within the five years prior to dosing, showing&#xD;
             no mechanical bowel obstruction or organic disorders of the large or small bowel.&#xD;
&#xD;
          7. For patients aged ≥ 50 years, documentation of the results of either a barium enema&#xD;
             with flexible sigmoidoscopy or colonoscopy performed within one year prior to dosing,&#xD;
             showing no mechanical bowel obstruction or organic disorders of the large or small&#xD;
             bowel.&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          1. Females who are pregnant, breast feeding, or planning a pregnancy during the proposed&#xD;
             study period.&#xD;
&#xD;
          2. Patients of any age with evidence of weight loss, anemia, or rectal bleeding and&#xD;
             without documentation of the results of either a flexible sigmoidoscopy or colonoscopy&#xD;
             performed during the 6 months prior to dosing.&#xD;
&#xD;
          3. Patients who have documented mechanical bowel obstruction (e.g., bowel obstruction due&#xD;
             to tumor, hernia), megacolon/megarectum, or diagnosis of pseudo-obstruction.&#xD;
&#xD;
          4. Patients with known or suspected organic disorders of the large or small bowel (e.g.,&#xD;
             inflammatory bowel disease, ulcerative colitis, Crohn's Disease) or constipation&#xD;
             secondary to a documented cause (e.g., surgery, bowel resection) or acute hernia or&#xD;
             with neurologic diseases or other diseases that cause motility problems for example&#xD;
             Parkinson's disease and spinal cord injury, etc.&#xD;
&#xD;
          5. Patients with a history of bowel resection.&#xD;
&#xD;
          6. Patients who are regularly using medications, which are known to cause constipation&#xD;
             (anticholinergics, narcotics, calcium channel blockers, tricyclic antidepressants,&#xD;
             colchicine, iron supplements, magnesium supplements).&#xD;
&#xD;
          7. Patients who are hospitalized for any gastrointestinal or abdominal surgical procedure&#xD;
             during the three months prior to dosing.&#xD;
&#xD;
          8. Patients with clinically significant cardiovascular, liver, lung, neurologic, renal or&#xD;
             psychiatric disorder, or clinically significant laboratory abnormalities (if&#xD;
             laboratory values exceed 2X Upper Limit of Normal the approval of medical monitor&#xD;
             should be taken into consideration before randomizing the patient).&#xD;
&#xD;
          9. Use of systemic antibiotics within four weeks prior to baseline.&#xD;
&#xD;
         10. Any current or planned significant change in diet during the study.&#xD;
&#xD;
         11. Participation in a study with any investigational medication within the past 30 days&#xD;
             before screening for this study or previous participation in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashis Patnaik, M.D</last_name>
    <role>Study Director</role>
    <affiliation>Dr. Reddy's Laboratories Limited</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shilpi Dhawan, M.D</last_name>
    <role>Study Director</role>
    <affiliation>Dr. Reddy's Laboratories Limited</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Health Specialists of the Southeast</name>
      <address>
        <city>Dothan</city>
        <state>Alabama</state>
        <zip>36305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Associates</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drug Research Group, LLC</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adobe Clinical Research , LLC</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visions Clinical Research</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SC Clinical Research, Inc</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Preferred Research Partners</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anaheim Clinical Trials</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnamics Inc,477 N. El Camino Real,Suite A100</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Medical Research Institute</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Center of Fresno</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93726</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Translational Research Group</name>
      <address>
        <city>North Hollywood</city>
        <state>California</state>
        <zip>91606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Staywell Research</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>v</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elias Research Associates</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benchmark Research</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center for CR</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shawn K Hassler</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SC Clinical Research, Inc ,1060 E. Foothill Blvd, Suite 204</name>
      <address>
        <city>Upland</city>
        <state>California</state>
        <zip>91786</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Progressive Clinical Research</name>
      <address>
        <city>Vista</city>
        <state>California</state>
        <zip>92084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Horizons Clinical Research Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Institute of Denver</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consultants of Clinical</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PAB Clinical Research</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Trials</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Care Family Rehabilitation and Research Center</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Research Unlimited, LLC</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Awareness ,Inc</name>
      <address>
        <city>Jupiter</city>
        <state>Florida</state>
        <zip>33458</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunrise Medical Research</name>
      <address>
        <city>Lauderdale Lakes</city>
        <state>Florida</state>
        <zip>33319</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Marcus Research Clinic</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmax Research Clinic</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Research Foundation , Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida International Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbus Clinical Services</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Medical Research Group , Inc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33186</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharma Research International, Inc</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharma Research International, Inc</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Research</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ormond Medical Arts Pharmaceutical</name>
      <address>
        <city>Ormond</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of Central Florida</name>
      <address>
        <city>Plant City</city>
        <state>Florida</state>
        <zip>33563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accord Clinical Research,LLC</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Research</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33709</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Research</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of Central Florida</name>
      <address>
        <city>Winter Haven</city>
        <state>Florida</state>
        <zip>33880</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Vernon Clinical Research</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Consultants PC</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Gastroenterology Assoc</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Digestive Care Center , PC</name>
      <address>
        <city>Stockbridge</city>
        <state>Georgia</state>
        <zip>30281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Atlanta</name>
      <address>
        <city>Stockbridge</city>
        <state>Georgia</state>
        <zip>30281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Research Associates</name>
      <address>
        <city>Newton</city>
        <state>Kansas</state>
        <zip>67114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Research Associates</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Integrity</name>
      <address>
        <city>Owensboro</city>
        <state>Kentucky</state>
        <zip>42303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Jefferson Gastro</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Clinical Trials Inc</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>2131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beacon Clinical Research</name>
      <address>
        <city>Brockton</city>
        <state>Massachusetts</state>
        <zip>02301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay State Clinical Trials, Inc.</name>
      <address>
        <city>Watertown</city>
        <state>Massachusetts</state>
        <zip>2472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute</name>
      <address>
        <city>Chesterfield</city>
        <state>Michigan</state>
        <zip>48047</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bayer Research</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GI Associates and Endoscopy Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quality Clinical Research, Inc</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Jersey Medical Research Center</name>
      <address>
        <city>Elizabeth</city>
        <state>New Jersey</state>
        <zip>07202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital,150 Bergen Street,B-134 Pharmacy</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosc Inc.</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NY Scientific,189-11 Jamaica Ave</name>
      <address>
        <city>Hollis</city>
        <state>New York</state>
        <zip>11423</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peters Medical Research</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Salisbury</name>
      <address>
        <city>Salisbury</city>
        <state>North Carolina</state>
        <zip>28144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Wilmington</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Winston-Salem, LLC</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Medical Research</name>
      <address>
        <city>Centerville</city>
        <state>Ohio</state>
        <zip>45459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rapid Medical Research , Inc</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Gastroenterology</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Detweiler Family Medicine and Associates, PC</name>
      <address>
        <city>Lansdale</city>
        <state>Pennsylvania</state>
        <zip>19446</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials Research Services, LLC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29650</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinsearch LLC</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCCA-CRS</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KRK Medical Research</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Consultants P.A</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Network</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Health Center</name>
      <address>
        <city>Pasadena</city>
        <state>Texas</state>
        <zip>77505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paragon Research Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quality Research, Inc</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Research</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Medical Research Associates , LLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78238</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Breco Research</name>
      <address>
        <city>Sugarland</city>
        <state>Texas</state>
        <zip>77479</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pioneer Research Solutions , Inc</name>
      <address>
        <city>Sugarland</city>
        <state>Texas</state>
        <zip>77479</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlottesville Medical Research Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BlueRidge Medical Research</name>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Research of Hampton Roads</name>
      <address>
        <city>Newport news</city>
        <state>Virginia</state>
        <zip>23606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>April 2, 2014</last_update_submitted>
  <last_update_submitted_qc>April 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lubiprostone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01674530
org study id: DRL-USG01-L/2012
nct id: NCT01674530
lead sponsor: 
collaborator: 
has dmc: No
The objective of this study is to evaluate the clinical equivalence and safety of the test
      formulation of Lubiprostone 24 mcg capsules manufactured by Dr Reddy's Laboratories Ltd
      compared to the marketed formulation AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo
      Pharmaceuticals, Inc.) in patients with confirmed Chronic Idiopathic Constipation
Constipation is a common gastrointestinal problem estimated to effect 2-27 % of the
      population in United States . It is found more commonly in women and elderly . The prevelance
      of constipation and growing demand for treatment dictate the need for safe and effective
      treatment options . Lubiprostone is the first chloride channel activator approved by FDA for
      long term treatment of chronic idiopathic constipation in adult men and women . To provide a
      generic medicine to the U.S population Dr Reddy's Laboratories intends to conduct this study
      to evaluate that the Lubiprostone manufactured by it is equally effective and safe as
      marketed AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Primary Analysis
time frame: Day 8
description: Clinical equivalence of the Test and Reference treatments and the superiority of each active treatment over the Placebo in the change from baseline in mean number of SBM's during the 7 day treatment period of the study
measure: Safety Analysis
time frame: Day 8
description: The type , frequency and severity of adverse events across the treatment groups will be analyzed at the end of the study
arm group label: Lubiprostone
arm group type: Experimental
description: Manufactured by Dr Reddy's Laboratories Ltd( 24 mcg administered for 7 days )
arm group label: AMITIZA®
arm group type: Active Comparator
description: Manufactured by Sucampo Pharmaceuticals(24 mcg administered for 7 days)
arm group label: Placebo
arm group type: Placebo Comparator
description: Manufactured by Dr Reddy's Laboratories Ltd ( 24 mcg adminstered for 7 days )
intervention type: Drug
intervention name: Lubiprostone
description: 24 mcg Capsules to be given in the experimental arm with Placebo Of AMITIZA
arm group label: Lubiprostone
intervention type: Drug
intervention name: Lubiprostone
description: 24 mcg Capsules with placebo of Lubiprostone ( Manufactured by Dr Reddy's Laboratories Ltd)
arm group label: AMITIZA®
intervention type: Drug
intervention name: Placebo
description: 24 mcg capsules of both experimental Lubiprostone and AMITIZA
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ashis Patnaik, M.D
role: Study Director
affiliation: Dr. Reddy's Laboratories Limited
last name: Shilpi Dhawan, M.D
role: Study Director
affiliation: Dr. Reddy's Laboratories Limited
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Constipation
mesh term: Lubiprostone