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Sponsored by: |
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
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Information provided by: | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
ClinicalTrials.gov Identifier: | NCT00338624 |
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 |
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Urination Disorders |
Drug: oxybutynin chloride extended release |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 350 |
Study Start Date: | May 2004 |
Study Completion Date: | June 2005 |
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.
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | McNeil Consumer & Specialty Pharmaceuticals Clinical Trial | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
Study ID Numbers: | CR004675 |
Study First Received: | June 16, 2006 |
Last Updated: | March 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00338624 |
Health Authority: | United States: Food and Drug Administration |
DITROPAN XL oxybutynin extended release tablets lower urinary tract symptoms |
Oxybutynin Urologic Diseases Urination Disorders Tamsulosin Mandelic Acids |
Parasympatholytics Anti-Infective Agents Neurotransmitter Agents Adrenergic Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Anti-Infective Agents, Urinary |
Adrenergic alpha-Antagonists Renal Agents Cholinergic Agents Pharmacologic Actions Muscarinic Antagonists Autonomic Agents Therapeutic Uses Adrenergic Antagonists Peripheral Nervous System Agents |