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.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: oxybutynin chloride extended release

Primary Measures

• Change of the total International Prostate Symptom Score (I-PSS) from baseline to Week 12 or the Final Visit.

Secondary Measures

• 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

Inclusion Criteria:

• Diagnosis of lower urinary tract symptoms with urgency and frequecy 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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

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

Overall Clinical Trial Officials and Contacts

McNeil Consumer & Specialty Pharmaceuticals Clinical Trial Study Director McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00338624

Study ID Number: CR004675

ClinicalTrials.gov Identifier: NCT00338624

Health Authority: United States: Food and Drug Administration

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