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.

This study has been completed.
Sponsor:
Information provided by:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
ClinicalTrials.gov Identifier:
NCT00338624
First received: June 16, 2006
Last updated: May 20, 2011
Last verified: April 2010
  Purpose

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 Intervention Phase
Urination Disorders
Drug: oxybutynin chloride extended release
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.:

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

Secondary Outcome 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

Enrollment: 420
Study Start Date: May 2004
Study Completion Date: June 2005
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

Ages Eligible for Study:   45 Years and older
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00338624     History of Changes
Other Study ID Numbers: CR004675
Study First Received: June 16, 2006
Last Updated: May 20, 2011
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents

ClinicalTrials.gov processed this record on September 16, 2014