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.

Urination Disorders Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00338624
• Other study ID #: CR004675
• Status: Completed
• Phase: Phase 3
• First received: June 16, 2006
• Last updated: May 20, 2011
• Start date: May 2004
• Est. completion date: June 2005

Study information

• Verified date: April 2010
• Source: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Urination Disorders

Intervention

Drug:
• oxybutynin chloride extended release

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the total International Prostate Symptom Score (I-PSS) from baseline to Week 12 or the Final Visit.
Secondary	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

External Links

•   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