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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.

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ClinicalTrials.gov Identifier: NCT00338624
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : May 24, 2011
Sponsor:
Information provided by:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

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.

Condition or disease Intervention/treatment Phase
Urination Disorders Drug: oxybutynin chloride extended release Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : May 2004
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Change of the total International Prostate Symptom Score (I-PSS) from baseline to Week 12 or the Final Visit.

Secondary Outcome Measures :
  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


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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00338624


Sponsors and Collaborators
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Investigators
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.

Additional Information:
ClinicalTrials.gov Identifier: NCT00338624     History of Changes
Other Study ID Numbers: CR004675
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: May 24, 2011
Last Verified: April 2010

Keywords provided by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.:
lower urinary tract symptoms
DITROPAN XL
oxybutynin extended release tablets

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Urination Disorders
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Tamsulosin
Oxybutynin
Mandelic Acids
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents