<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/NCT02244281</url>
  </required_header>
  <id_info>
    <org_study_id>527.25</org_study_id>
    <nct_id>NCT02244281</nct_id>
  </id_info>
  <brief_title>Study of FLOMAX® Versus Placebo in Female Patients With Lower Urinary Tract Symptoms (LUTS) With a Significant Component of Voiding Symptoms</brief_title>
  <official_title>An Eight-week, Double-blind, Randomized, Parallel Group Design, Multicenter Study of FLOMAX® Capsules, 0.4 mg Daily Versus Placebo, in Female Patients With Lower Urinary Tract Symptoms (LUTS) With a Significant Component of Voiding Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      1. To study the symptomatic improvement in LUTS afforded by FLOMAX® capsules, 0.4 mg daily&#xD;
           compared to placebo, in female patients with lower urinary tract symptoms (LUTS) with a&#xD;
           significant component of voiding symptoms&#xD;
&#xD;
        2. To study the improvement afforded by FLOMAX® capsules versus placebo, in this patient&#xD;
           population, in quality of life&#xD;
&#xD;
        3. To assess the safety and tolerability of FLOMAX® capsules, 0.4 mg compared to placebo,&#xD;
           in women suffering from LUTS with a significant component of voiding symptoms&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2001</start_date>
  <primary_completion_date type="Actual">November 2003</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>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of efficacy on a American Urological Association (AUA) Symptom Score Index</measure>
    <time_frame>Up to day 56 after first study drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of Quality of Life on a incontinence impact questionary and urogenital distress inventory</measure>
    <time_frame>Up to day 56 after first study drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of urinary frequency and nocturia on a seventy-two hour voiding diary</measure>
    <time_frame>Up to day 28 after first study drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of urinary obstruction</measure>
    <time_frame>Up to day 56 after first study drug administration</time_frame>
    <description>by uroflowmetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Post-Void Residual volume</measure>
    <time_frame>Up to day 56 after first study drug administration</time_frame>
    <description>by pelvic ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of lower urinary tract symptoms of obstruction</measure>
    <time_frame>Up to day 56 after first study drug administration</time_frame>
    <description>(voiding, Items 1, 3, 5 and 6), irritation (storage, Items 2, 4 and 7) and nocturia (Item 7) by AUA Symptom Score Index sub scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to day 56 after first study drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Lower Urinary Tract Symptoms</condition>
  <arm_group>
    <arm_group_label>FLOMAX®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tamsulosin hydrochloride</intervention_name>
    <arm_group_label>FLOMAX®</arm_group_label>
    <other_name>FLOMAX®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult women, 18 years of age or older, currently diagnosed with LUTS with a&#xD;
             significant component of voiding symptoms&#xD;
&#xD;
          -  The Patient must be diagnosed with one of the following: hesitancy, intermittency,&#xD;
             difficulty in bladder emptying, or straining to void&#xD;
&#xD;
          -  Patients must have had an AUA Symptom Score of 13 or higher&#xD;
&#xD;
          -  Obstruction component of AUA Symptom Score (Items 1, 3, 5, and 6) had to be 5 points&#xD;
             or higher&#xD;
&#xD;
          -  Patients that are currently taking alpha-blockers or anticholinergics must discontinue&#xD;
             the drugs at least 2 weeks prior to Visit 1&#xD;
&#xD;
          -  Patients should show compliance of greater than or equal to 80% with placebo usage&#xD;
&#xD;
          -  Patients should be surgically sterile, or 2 years postmenopausal, or practicing a&#xD;
             medically acceptable method of birth control&#xD;
&#xD;
          -  Patients must have a negative urine Beta Human Chorionic Gonadotropin (beta-HCG)&#xD;
&#xD;
          -  Patients must be able to provide written informed consent prior to participation in&#xD;
             the study in accordance with regulatory requirements&#xD;
&#xD;
          -  Patients must be judged by the investigator to be reliable and should comply with all&#xD;
             tests and examinations stipulated in the protocol&#xD;
&#xD;
          -  All patients should be able to understand and read English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who presented with an active urinary tract infection or who had presented&#xD;
             with two or more culture positive urinary tract infections within 6 months of the&#xD;
             study&#xD;
&#xD;
          -  Patients with significant prolapse beyond the hymenal ring, per the investigator's&#xD;
             judgment&#xD;
&#xD;
          -  Patients who had taken anticholinergic medications for the treatment of other urologic&#xD;
             conditions and had not discontinued their use 2 weeks prior to study entry&#xD;
&#xD;
          -  Patients who had a history or active condition of renal or urethral calculi, urethral&#xD;
             colic, mechanical outlet obstruction (i.e., bladder neck contracture or stricture,&#xD;
             bladder tumor, or bladder calculi) 3 months prior to study entry&#xD;
&#xD;
          -  Patients with a history of bladder, vaginal or urethral surgery in the last 6 months&#xD;
&#xD;
          -  Patients who have a history of microscopic hematuria and not had a recent work-up&#xD;
             including cystoscopy and upper urinary tract study (within 6 months of screening) or a&#xD;
             diagnosis of a condition that may exclude the patient in the opinion of the&#xD;
             investigator&#xD;
&#xD;
          -  Abnormal urinalysis as defined by the following mid-stream, clean-catch specimen&#xD;
             results:&#xD;
&#xD;
               -  A bacterial colony count of greater than 100,000/ml.&#xD;
&#xD;
               -  More than 10 leukocytes per high power field with more than two granular casts&#xD;
                  per high power field.&#xD;
&#xD;
               -  More than 10 red blood cells (non-menstrual tainted urine sample) per high power&#xD;
                  field.&#xD;
&#xD;
               -  Proteinuria &gt;+1 (equivalent to &gt;30 mg/dL)&#xD;
&#xD;
          -  Patients presenting with any of the following: history of a neurogenic bladder due to&#xD;
             any neurologic condition that might involve the lower urinary tract, active urinary&#xD;
             stone disease, previous pelvic radiotherapy, perirectal inflammatory disorder or&#xD;
             inflammatory bowel disease&#xD;
&#xD;
          -  Patients that had a history of sexually transmitted diseases of the genitourinary&#xD;
             system such as syphilis, herpes, gonorrhea, chlamydia, mycoplasma, trichomonas (within&#xD;
             3 months of the study) or any other diagnosis that in the opinion of the investigator&#xD;
             may have excluded the patient&#xD;
&#xD;
          -  Patients that are pregnant or breast-feeding&#xD;
&#xD;
          -  The Patient has significant pelvic pain that demands treatment with narcotics&#xD;
&#xD;
          -  Large fluctuations in LUTS symptoms over the last 6 months (i.e., symptoms appearing&#xD;
             and disappearing with unusual rapidity)&#xD;
&#xD;
          -  Any baseline (Visit 1) laboratory serum test with the following values: Hemoglobin:&#xD;
             &lt;11.0 g/dL, Leukocytes: &lt;3,000 per mm3, Liver enzymes [serum glutamic oxaloacetic&#xD;
             transaminase / Aspartate aminotransferase (SGOT/AST), serum glutamic pyruvic&#xD;
             transaminase / Alanine transaminase (SGPT/ALT) or alkaline phosphatase]: more than two&#xD;
             times the upper limit of normal at baseline (Visit 1). Serum creatinine more than two&#xD;
             times the upper limit of normal at baseline (Visit 1)&#xD;
&#xD;
          -  Patients with a diagnosis of cancer, except basal cell carcinoma, within the past 5&#xD;
             years. (Note: Contact the Trial Clinical Monitor with any specific or special&#xD;
             circumstances regarding the entry of a cancer patient.)&#xD;
&#xD;
          -  Participation in another drug study within 4 weeks of baseline (Visit 1)&#xD;
&#xD;
          -  Clinically relevant conditions which may interfere with the patient's ability to&#xD;
             participate in the study including, but not limited to, the following: neurologic,&#xD;
             gastrointestinal, cardiovascular, hepatic, renal, psychiatric, hematologic or&#xD;
             respiratory disease and clinically relevant laboratory abnormalities not mentioned&#xD;
             above (e.g., hematuria) based upon the clinical judgment of the investigator&#xD;
&#xD;
          -  Patients who have been receiving cimetidine, ranitidine and warfarin medications&#xD;
             within 2 weeks of screening and who would potentially use such medication during the&#xD;
             course of the trial&#xD;
&#xD;
          -  Patients with known hypersensitivity to FLOMAX® (tamsulosin hydrochloride) or other&#xD;
             alpha-blockers&#xD;
&#xD;
          -  Patients with a history of myocardial infarction within 6 months of baseline (Visit 1)&#xD;
&#xD;
          -  Patients with uncontrolled hypertension (systolic &gt;160 mmHg, diastolic &gt;100 mmHg) and&#xD;
             patients with severe hypotension (systolic &lt;90 mmHg) after 5 minutes of sitting&#xD;
&#xD;
          -  Patients who have been using the following drugs, within 2 weeks prior to screening&#xD;
             (Visit 1), and who are unable to discontinue these drugs over the course of the study&#xD;
&#xD;
               1. Alpha-adrenergic blocking agents&#xD;
&#xD;
               2. Alpha-adrenergic medication&#xD;
&#xD;
               3. Drugs with systemic anticholinergic activity including antihistamines.&#xD;
                  Antihistamines allowed are Allegra®, Claritin® and Zyrtec®&#xD;
&#xD;
               4. Antispasmodics or muscle relaxants&#xD;
&#xD;
               5. Parasympathomimetics, cholinomimetics, and/or similar drugs&#xD;
&#xD;
          -  Patients with poorly controlled diabetes mellitus based upon urine with 2+ (or&#xD;
             greater) glucose on urinalysis, performed at screening (Visit 1).&#xD;
&#xD;
          -  Patients who suffer from neurological diseases affecting the bladder (i.e., multiple&#xD;
             sclerosis, Parkinson's disease, stroke, and any bladder trauma that may have been an&#xD;
             exclusion criterion in the opinion of the investigator)&#xD;
&#xD;
          -  Patients that have a neurological impairment or psychiatric disorder that prevents&#xD;
             their comprehension of consent and their ability to comply with the protocol&#xD;
&#xD;
          -  Patients who had been diagnosed with interstitial cystitis according to the National&#xD;
             Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) criteria&#xD;
&#xD;
          -  Patients that had a history of urethral syndrome whose treatment was other than&#xD;
             dilation. Patients treated by dilation 3 months prior to study entry were allowed to&#xD;
             participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 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>Lower Urinary Tract Symptoms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tamsulosin</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/NCT02244281
org study id: 527.25
nct id: NCT02244281
lead sponsor: 
1. To study the symptomatic improvement in LUTS afforded by FLOMAX® capsules, 0.4 mg daily
           compared to placebo, in female patients with lower urinary tract symptoms (LUTS) with a
           significant component of voiding symptoms

        2. To study the improvement afforded by FLOMAX® capsules versus placebo, in this patient
           population, in quality of life

        3. To assess the safety and tolerability of FLOMAX® capsules, 0.4 mg compared to placebo,
           in women suffering from LUTS with a significant component of voiding symptoms
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Assessment of efficacy on a American Urological Association (AUA) Symptom Score Index
time frame: Up to day 56 after first study drug administration
measure: Assessment of Quality of Life on a incontinence impact questionary and urogenital distress inventory
time frame: Up to day 56 after first study drug administration
measure: Assessment of urinary frequency and nocturia on a seventy-two hour voiding diary
time frame: Up to day 28 after first study drug administration
measure: Assessment of urinary obstruction
time frame: Up to day 56 after first study drug administration
description: by uroflowmetry
measure: Assessment of Post-Void Residual volume
time frame: Up to day 56 after first study drug administration
description: by pelvic ultrasound
measure: Assessment of lower urinary tract symptoms of obstruction
time frame: Up to day 56 after first study drug administration
description: (voiding, Items 1, 3, 5 and 6), irritation (storage, Items 2, 4 and 7) and nocturia (Item 7) by AUA Symptom Score Index sub scores
measure: Number of patients with adverse events
time frame: Up to day 56 after first study drug administration
arm group label: FLOMAX®
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: tamsulosin hydrochloride
arm group label: FLOMAX®
other name: FLOMAX®
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Lower Urinary Tract Symptoms
mesh term: Tamsulosin