Status:
COMPLETED
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.
Lead Sponsor:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Urination Disorders
Eligibility:
MALE
45+ years
Phase:
PHASE3
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 measur...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00338624
Start Date
May 1 2004
End Date
June 1 2005
Last Update
May 24 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.