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.
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.
1 other identifier
interventional
420
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2004
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 16, 2006
CompletedFirst Posted
Study publicly available on registry
June 20, 2006
CompletedMay 24, 2011
April 1, 2010
June 16, 2006
May 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of the total International Prostate Symptom Score (I-PSS) from baseline to Week 12 or the Final Visit.
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PMID: 37160401DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 16, 2006
First Posted
June 20, 2006
Study Start
May 1, 2004
Study Completion
June 1, 2005
Last Updated
May 24, 2011
Record last verified: 2010-04