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.
Information source: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urination Disorders
Intervention: oxybutynin chloride extended release (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. Official(s) and/or principal investigator(s):
McNeil Consumer & Specialty Pharmaceuticals Clinical Trial, Study Director, Affiliation: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change of the total International Prostate Symptom Score (I-PSS) from baseline to Week 12 or the Final Visit.
Secondary outcome: 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
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.
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Diagnosis of lower urinary tract symptoms with urgency and frequecy 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
Locations and Contacts
Additional Information
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
Starting date: May 2004
Ending date: June 2005
Last updated: March 28, 2008
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