<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/NCT01664637</url>
  </required_header>
  <id_info>
    <org_study_id>TZP-102-CL-G004</org_study_id>
    <nct_id>NCT01664637</nct_id>
  </id_info>
  <brief_title>Diabetic Gastroparesis Efficacy/Safety Study of TZP-102</brief_title>
  <acronym>DIGEST</acronym>
  <official_title>A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Evaluation of the Efficacy and Safety of TZP-102 Given Orally Three Times a Day for the Treatment of Symptoms Associated With Diabetic Gastroparesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tranzyme, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tranzyme, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the safety and effectiveness of 10 mg TZP-102 given&#xD;
      prior to meals three times a day compared to placebo (capsule that looks like active study&#xD;
      drug but contains no active drug), administered for 12 weeks, in diabetic subjects with&#xD;
      symptoms associated with gastroparesis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient efficacy in planned interim futility analysis&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">February 2013</completion_date>
  <primary_completion_date type="Anticipated">January 2013</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in symptoms associated with diabetic gastroparesis</measure>
    <time_frame>12 Weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in health-related quality of life</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events (AEs), vital signs, ECGs, clinical laboratory parameters</measure>
    <time_frame>12 Weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Diabetic Gastroparesis</condition>
  <arm_group>
    <arm_group_label>TZP-102 three times a day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 mg TZP-102 will be taken 30 minutes prior to each main meal for a total of three daily doses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo three times a day</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo will be taken 30 minutes prior to each main meal for a total of three daily doses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>10 mg TZP-102</intervention_name>
    <description>One oval-shaped, opaque-white, hard gelatin capsule containing active ingredient will be taken orally three times a day for 12 weeks</description>
    <arm_group_label>TZP-102 three times a day</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>One oval-shaped, opaque-white, hard gelatin capsule of placebo indistinguishable from active drug will be taken orally three times a day for 12 weeks</description>
    <arm_group_label>Placebo three times a day</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 80 years of age inclusive&#xD;
&#xD;
          -  Type 1 or type 2 diabetes mellitus&#xD;
&#xD;
          -  History of symptoms of gastroparesis for at least 3 months leading up to the Screening&#xD;
             Visit&#xD;
&#xD;
          -  Documented delayed gastric emptying&#xD;
&#xD;
          -  Upper gastrointestinal obstruction ruled out by endoscopy or barium scan&#xD;
&#xD;
          -  Concomitant medications must be stable for at least 2 weeks leading up to the&#xD;
             Screening visit and must be maintained during the study.&#xD;
&#xD;
          -  Females of child-bearing potential must have a negative serum pregnancy test and use&#xD;
             (and agree to continue to use throughout the study) an acceptable form of&#xD;
             contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gastrectomy, bariatric surgery, fundoplication or vagotomy/pyloroplasty&#xD;
&#xD;
          -  Has had or plans to have endoscopic pyloric injections of botulinum toxin within 6&#xD;
             months prior to the Screening Visit or during the study&#xD;
&#xD;
          -  NG, PEG or PEJ feeding tube or inpatient hospitalization for gastroparesis within 2&#xD;
             weeks prior to the Screening Visit&#xD;
&#xD;
          -  Required parenteral nutrition for treatment of gastroparesis within 2 months prior to&#xD;
             the Screening Visit&#xD;
&#xD;
          -  Active gastric pacemaker within 3 months prior to the Screening Visit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elsa Mondou, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Tranzyme, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>North Little Rock</city>
        <state>Arkansas</state>
        <zip>72117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Inverness</city>
        <state>Florida</state>
        <zip>34452</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33183</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>New Smyrna Beach</city>
        <state>Florida</state>
        <zip>32168</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Anderson</city>
        <state>Indiana</state>
        <zip>46106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Monroe</city>
        <state>Louisiana</state>
        <zip>71201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Mexico</city>
        <state>Missouri</state>
        <zip>65265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Salisbury</city>
        <state>North Carolina</state>
        <zip>28144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Bialystok</city>
        <zip>15732</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Bialystok</city>
        <zip>15950</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85094</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Kielce</city>
        <zip>25035</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Krakow</city>
        <zip>31530</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Lodz</city>
        <zip>90251</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Lublin</city>
        <zip>20090</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Lublin</city>
        <zip>20607</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Olsztyn</city>
        <zip>10561</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Rzeszow</city>
        <zip>35073</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Warsaw</city>
        <zip>02097</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tranzyme Investigational Site</name>
      <address>
        <city>Zgierz</city>
        <zip>95100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>December 18, 2012</last_update_submitted>
  <last_update_submitted_qc>December 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diabetic gastroparesis</keyword>
  <keyword>delayed gastric emptying</keyword>
  <keyword>gastroparesis</keyword>
  <keyword>diabetes mellitus, Type 1</keyword>
  <keyword>diabetes mellitus, Type 2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroparesis</mesh_term>
  </condition_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/NCT01664637
org study id: TZP-102-CL-G004
nct id: NCT01664637
lead sponsor: 
has dmc: Yes
The purpose of this study is to test the safety and effectiveness of 10 mg TZP-102 given
      prior to meals three times a day compared to placebo (capsule that looks like active study
      drug but contains no active drug), administered for 12 weeks, in diabetic subjects with
      symptoms associated with gastroparesis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in symptoms associated with diabetic gastroparesis
time frame: 12 Weeks
measure: Change from baseline in health-related quality of life
time frame: 12 Weeks
measure: Adverse events (AEs), vital signs, ECGs, clinical laboratory parameters
time frame: 12 Weeks
arm group label: TZP-102 three times a day
arm group type: Experimental
description: 10 mg TZP-102 will be taken 30 minutes prior to each main meal for a total of three daily doses.
arm group label: Placebo three times a day
arm group type: Placebo Comparator
description: Placebo will be taken 30 minutes prior to each main meal for a total of three daily doses.
intervention type: Drug
intervention name: 10 mg TZP-102
description: One oval-shaped, opaque-white, hard gelatin capsule containing active ingredient will be taken orally three times a day for 12 weeks
arm group label: TZP-102 three times a day
intervention type: Drug
intervention name: Placebo
description: One oval-shaped, opaque-white, hard gelatin capsule of placebo indistinguishable from active drug will be taken orally three times a day for 12 weeks
arm group label: Placebo three times a day
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Elsa Mondou, M.D.
role: Study Director
affiliation: Tranzyme, Inc.
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country: Poland
country: United States
responsible party type: Sponsor
mesh term: Gastroparesis