<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/NCT02244294</url>
  </required_header>
  <id_info>
    <org_study_id>527.26</org_study_id>
    <nct_id>NCT02244294</nct_id>
  </id_info>
  <brief_title>FLOMAX® Versus Placebo, in Male Patients With Acute Urinary Retention Related to Benign Prostatic Hyperplasia (BPH)</brief_title>
  <official_title>A Two Phase, Double-blinded, Randomized, Parallel Group Design, Multicenter Study of FLOMAX® Capsules, 0.4 mg Versus Placebo, in Male Patients With Acute Urinary Retention Related to Benign Prostatic Hyperplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      To establish whether the administration of FLOMAX® improves the outcome of a trial without&#xD;
      catheter (TWOC) after an episode of acute urinary retention and to determine whether&#xD;
      spontaneous voiding is maintained over the course of six months of active treatment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2001</start_date>
  <primary_completion_date type="Actual">June 2005</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>Successful spontaneous voiding after urethral catheter removal</measure>
    <time_frame>Up to 96 hours after start of treatment</time_frame>
    <description>For Phase I of the trial</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maintenance of successful spontaneous voiding</measure>
    <time_frame>Up to 6 months after start of treatment</time_frame>
    <description>For Phase II of the trial</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in voided urine volume</measure>
    <time_frame>Up to 6 months after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of post-void residual urine volume</measure>
    <time_frame>Up to 6 months after start of treatment</time_frame>
    <description>by ultrasound or bladder scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to recurrence of AUR</measure>
    <time_frame>Up to 6 months after start of treatment</time_frame>
    <description>For phase II of the trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically significant changes from baseline in vital signs</measure>
    <time_frame>Pre-dose, up to 6 months after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">176</enrollment>
  <condition>Prostate Hyperplasia</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>FLOMAX® capsules</intervention_name>
    <arm_group_label>FLOMAX®</arm_group_label>
    <other_name>Tamsulosin hydrochloride</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo capsules</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Phase I&#xD;
&#xD;
          -  Adult men, 45 years of age or older, diagnosed with acute urinary retention due to BPH&#xD;
&#xD;
          -  Patients who have never taken alpha-blockers or discontinued taking alpha-blockers 72&#xD;
             hours or more prior to entrance into this study&#xD;
&#xD;
          -  Patients that have been treated with an indwelling urethral catheter as treatment for&#xD;
             acute urinary retention (AUR) due to BPH&#xD;
&#xD;
          -  Patients must be judged by the investigator to be reliable and willing to comply with&#xD;
             all tests and examinations stipulated in the protocol&#xD;
&#xD;
          -  All patients must be willing to give meaningful, written, informed consent prior to&#xD;
             participation in the trial, in accordance with regulatory requirements. Patients must&#xD;
             also have sufficient understanding to communicate effectively with the investigator&#xD;
&#xD;
        Phase II - Patients who voided spontaneously, at least 100 mL and a post-void residual&#xD;
        volume of ≤ 300 mL, at Visit 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Phase I&#xD;
&#xD;
          -  Patients diagnosed with a symptomatic/active urinary tract infection (UTI) or an&#xD;
             abnormal urine culture at baseline or 2 or more UTIs within the last six months. An&#xD;
             abnormal urine culture was defined as:&#xD;
&#xD;
               -  A bacterial colony count of greater than or equal to 100,000 CFU/mL or&#xD;
&#xD;
               -  A bacterial colony count of greater than or equal to 100 CFU/mL of a known&#xD;
                  urinary pathogen in a symptomatic patient&#xD;
&#xD;
          -  Patients that have a distended bladder volume greater than 1.5 liters (1500 ml) of&#xD;
             retention as measured by initial catheter urine volume&#xD;
&#xD;
          -  Patients with history of sexually transmitted disease within last two years&#xD;
&#xD;
          -  Patients with active genital herpes disease whose urinary function was impacted due to&#xD;
             the disease&#xD;
&#xD;
          -  Patients who have a history of mechanical outlet obstruction excluding BPH (i.e.,&#xD;
             bladder neck contracture or stricture, bladder tumor, or bladder calculi)&#xD;
&#xD;
          -  Patients with urethral stricture disease&#xD;
&#xD;
          -  Patients with a history of bladder, prostate, or urethral surgery in the last three&#xD;
             months&#xD;
&#xD;
          -  Patients presenting with AUR who were not been seen within 5 days of urethral catheter&#xD;
             placement&#xD;
&#xD;
          -  Patients presenting with any of the following: active urinary stone disease, previous&#xD;
             pelvic radiotherapy, perirectal inflammatory disorders or inflammatory bowel disease&#xD;
&#xD;
          -  Participation in another drug study within 30 days of 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 receiving cimetidine, ranitidine or warfarin within two weeks of study start&#xD;
             date and who would potentially use such medications during the course of the trial&#xD;
&#xD;
          -  Patients currently treated with finasteride (PROSCAR®) and who would not discontinue&#xD;
             its use upon entrance into the study&#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 six months of baseline&#xD;
&#xD;
          -  Patients with uncontrolled hypertension (systolic &gt; 160 mmHg, diastolic &gt; 100 mmHg)&#xD;
             and patients with severe hypotension (systolic &lt; 90 mmHg)&#xD;
&#xD;
          -  Patients who have been using the following drugs, 72 hours prior to study start date,&#xD;
             or who are unable to discontinue these drugs over the course of the study:&#xD;
&#xD;
               -  Alpha-adrenergic medication&#xD;
&#xD;
               -  Drugs with systemic anticholinergic activity including antihistamines. The&#xD;
                  following antihistamines are allowed: ALLEGRA®, CLARITIN® or ZYRTEX®&#xD;
&#xD;
               -  Antispasmodics or muscle relaxants&#xD;
&#xD;
               -  Parasympathomimetics, cholinomimetics or similar drug&#xD;
&#xD;
          -  Patients that have poorly controlled diabetes mellitus who suffer from peripheral&#xD;
             neuropathy or diabetic cystopathy&#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 be an&#xD;
             exclusion criterion in the opinion of the investigator&#xD;
&#xD;
          -  Patients with a neurological impairment or psychiatric disorder that prevents their&#xD;
             comprehension of the informed consent and/or the ability to comply with the protocol&#xD;
&#xD;
          -  Patients with a urine volume at the initial catheterization less than 300 mL&#xD;
&#xD;
          -  Patients with a diagnosis of active cancer, except basal cell carcinoma, within 5&#xD;
             years or less&#xD;
&#xD;
          -  Patients who had a transurethral resection of the prostate (TURP) within 5 years or&#xD;
             less of study enrollment and irreversible urethral damage due to the procedure&#xD;
&#xD;
        Phase II&#xD;
&#xD;
        - Patients with clinically, significant abnormal lab results including any baseline&#xD;
        laboratory serum test with the following values:&#xD;
&#xD;
          -  Hemoglobin &lt; 11.0 g/dL&#xD;
&#xD;
          -  Leukocytes &lt; 3,000 per mm3&#xD;
&#xD;
          -  Liver enzymes [aspartate aminotransferase (SGOT), alanine transaminase (SGPT) and&#xD;
             alkaline phosphatase]: more than two times the upper limit of normal at baseline&#xD;
&#xD;
          -  Serum creatinine more than two times the upper limit of normal at Visit 1&#xD;
&#xD;
          -  Patients with clot retention, persistent gross hematuria (Visit 3 only), prostatitis,&#xD;
             a symptomatic/active urinary tract infection (UTI) or an abnormal baseline urine&#xD;
             culture&#xD;
&#xD;
          -  An abnormal urine culture was defined as:&#xD;
&#xD;
          -  A bacterial colony count of greater than or equal to 100,000 colony forming units&#xD;
             (CFU)/mL or&#xD;
&#xD;
          -  A bacterial colony count of greater than or equal to 100 CFU/mL of a kown urinary&#xD;
             pathogen in a symptomatic patient&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>45 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>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Urinary Retention</mesh_term>
    <mesh_term>Hyperplasia</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/NCT02244294
org study id: 527.26
nct id: NCT02244294
lead sponsor: 
To establish whether the administration of FLOMAX® improves the outcome of a trial without
      catheter (TWOC) after an episode of acute urinary retention and to determine whether
      spontaneous voiding is maintained over the course of six months of active treatment
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Successful spontaneous voiding after urethral catheter removal
time frame: Up to 96 hours after start of treatment
description: For Phase I of the trial
measure: Maintenance of successful spontaneous voiding
time frame: Up to 6 months after start of treatment
description: For Phase II of the trial
measure: Change in voided urine volume
time frame: Up to 6 months after start of treatment
measure: Determination of post-void residual urine volume
time frame: Up to 6 months after start of treatment
description: by ultrasound or bladder scan
measure: Time to recurrence of AUR
time frame: Up to 6 months after start of treatment
description: For phase II of the trial
measure: Clinically significant changes from baseline in vital signs
time frame: Pre-dose, up to 6 months after start of treatment
measure: Number of patients with adverse events
time frame: Up to 6 months
arm group label: FLOMAX®
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: FLOMAX® capsules
arm group label: FLOMAX®
other name: Tamsulosin hydrochloride
intervention type: Drug
intervention name: Placebo capsules
arm group label: Placebo
criteria: 
gender: Male
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Prostatic Hyperplasia
mesh term: Urinary Retention
mesh term: Hyperplasia
mesh term: Tamsulosin