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An Effectiveness and Safety Study Comparing Oxybutynin Chloride Plus FLOMAX (Tamsulosin HCl) and Placebo Plus FLOMAX (Tamsulosin HCl) for the Treatment of Lower Urinary Tract Symptoms.

Primary Purpose

Urination Disorders

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
oxybutynin chloride extended release
Sponsored by
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urination Disorders focused on measuring lower urinary tract symptoms, DITROPAN XL, oxybutynin extended release tablets

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of lower urinary tract symptoms with urgency and frequency with or without urge incontinence have had at least 4 weeks of 0.4 mg/day tamsulosin therapy an International Prostate Symptom Score (I-PSS) >=13 irritative component I-PSS score >= 8 max flow >= 8ml/sec with voided volume >= 125 ml, post-void residual volume <= 150 ml on two occasions. Exclusion Criteria: Clinically significant medical problems or other organ abnormality or pathology Prostate-Specific Antigen (PSA) >= 4 ng/ml history of inability to empty bladder completely or not at all uncontrolled narrow angle glaucoma history of any prostate surgery or treatment history of significant gastrointestinal problems.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Change of the total International Prostate Symptom Score (I-PSS) from baseline to Week 12 or the Final Visit.

    Secondary Outcome Measures

    At all timepoints assessed and final visit: I-PSS (total score, irritative component score, quality of life score); Symptom Problem Index score; Urgency and frequency scales scores; Incontinence Indicator scale score

    Full Information

    First Posted
    June 16, 2006
    Last Updated
    May 20, 2011
    Sponsor
    McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00338624
    Brief Title
    An Effectiveness and Safety Study Comparing Oxybutynin Chloride Plus FLOMAX (Tamsulosin HCl) and Placebo Plus FLOMAX (Tamsulosin HCl) for the Treatment of Lower Urinary Tract Symptoms.
    Official Title
    A Double-Blind, Randomized, Parallel Group Trial of Ditropan XL (Oxybutynin Chloride) Extended Release Tablets or Placebo in Combination With FLOMAX (Tamsulosin Hydrochloride) for the Treatment of Lower Urinary Tract Symptoms.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and effectiveness of oxybutynin extended release tablets 10 mg plus tamsulosin HCl 0.4 mg in the treatment of lower urinary tract symptoms as measured by change of the total International Prostate Symptom Score (I-PSS) from baseline to Week 12 or the Final Visit.
    Detailed Description
    The objective of this double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), parallel group trial is to evaluate the safety and effectiveness of oxybutynin extended release tablets 10 mg per day for 12 weeks in conjunction with an alpha-blocker for the treatment of lower urinary tract symptoms (LUTS). The hypothesis of the study is that oxybutynin extended release tablets 10 mg plus tamsulosin 0.4 mg will be more effective than tamsulosin 0.4 mg plus placebo in the treatment of lower urinary tract symptoms as measured by change of the total International Prostate Symptom Score (I-PSS) from baseline to Week 12 or the Final Visit. Safety assessments include Peak Flow Rate (PFR) and Post-Void Residual (PVR) volume, adverse events, vital signs and physical exams. Patients will receive oxybutynin extended release 10 mg plus tamsulosin 0.4 mg or placebo plus tamsulosin 0.4 mg every day for 12 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urination Disorders
    Keywords
    lower urinary tract symptoms, DITROPAN XL, oxybutynin extended release tablets

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    420 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    oxybutynin chloride extended release
    Primary Outcome Measure Information:
    Title
    Change of the total International Prostate Symptom Score (I-PSS) from baseline to Week 12 or the Final Visit.
    Secondary Outcome Measure Information:
    Title
    At all timepoints assessed and final visit: I-PSS (total score, irritative component score, quality of life score); Symptom Problem Index score; Urgency and frequency scales scores; Incontinence Indicator scale score

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of lower urinary tract symptoms with urgency and frequency with or without urge incontinence have had at least 4 weeks of 0.4 mg/day tamsulosin therapy an International Prostate Symptom Score (I-PSS) >=13 irritative component I-PSS score >= 8 max flow >= 8ml/sec with voided volume >= 125 ml, post-void residual volume <= 150 ml on two occasions. Exclusion Criteria: Clinically significant medical problems or other organ abnormality or pathology Prostate-Specific Antigen (PSA) >= 4 ng/ml history of inability to empty bladder completely or not at all uncontrolled narrow angle glaucoma history of any prostate surgery or treatment history of significant gastrointestinal problems.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial
    Organizational Affiliation
    McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=1088&filename=CR004675_CSR.pdf
    Description
    An effectiveness and safety study comparing oxybutnin chloride plus FLOMAX (tamsulosin HCL) and placebo plus FLOMAX (tamsulosin HCL) for the treatment of lower urinary tract symptoms

    Learn more about this trial

    An Effectiveness and Safety Study Comparing Oxybutynin Chloride Plus FLOMAX (Tamsulosin HCl) and Placebo Plus FLOMAX (Tamsulosin HCl) for the Treatment of Lower Urinary Tract Symptoms.

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