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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.
ClinicalTrials.gov processed this data on August 23, 2015
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, a Division of Mc Neil-PPC, Inc. 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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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 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.

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
Last updated: May 20, 2011

Page last updated: August 23, 2015

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