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.

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
• Treatments: Mandelic Acids; Oxybutynin; Tamsulosin

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.