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Sponsored by: |
Alza Corporation, DE, USA |
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Information provided by: | Alza Corporation, DE, USA |
ClinicalTrials.gov Identifier: | NCT00293839 |
The purpose of this study is to compare the efficacy of DITROPAN® XL (oxybutynin chloride) Extended-Release Tablets and DETROL® LA (tolterodine tartrate extended-release capsules) in the reduction of urge urinary incontinence episodes during a 12-week treatment period in patients with overactive bladder. The secondary objective is to compare the tolerability of DITROPAN® XL (oxybutynin chloride) and DETROL® LA (tolterodine tartrate) during a 12-week treatment period.
Condition | Intervention | Phase |
---|---|---|
Urinary Incontinence |
Drug: oxybutynin chloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Comparison of the Efficacy and Tolerability of DITROPAN® XL and DETROL® LA in the Treatment of Overactive Bladder |
Estimated Enrollment: | 750 |
Study Start Date: | November 2001 |
Estimated Study Completion Date: | December 2002 |
The objective of this study is to compare the efficacy and tolerability of DITROPAN® XL 10 mg once-daily and DETROL® LA 4 mg once-daily in the reduction of urge urinary incontinence episodes in female patients with overactive bladder. This is a multicenter, randomized, double-blind, parallel-group study with two active treatments. Screened patients are qualified for the study based on information obtained from seven consecutive 24-hour urinary diaries completed during the Baseline Week, and other eligibility criteria. Qualifying patients receive 12 weeks of treatment with DITROPAN® XL or DETROL® LA, with clinical visits at the end of Weeks 2, 4, 8, and 12. Safety evaluations during the study include the collection of adverse events, laboratory tests including blood chemistry and urinalysis, physical examinations, vital signs (blood pressure and heart rate) and post-void residual urine volume.
Over-encapsulated DITROPAN® XL, 10 mg tablets once-daily by mouth or over-encapsulated DETROL® LA, 4 mg capsules once daily by mouth. The treatment phase of the study runs for 12 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR004570 |
Study First Received: | February 16, 2006 |
Last Updated: | April 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00293839 |
Health Authority: | United States: Food and Drug Administration |
overactive bladder |
Oxybutynin Signs and Symptoms Urinary Bladder, Overactive Cystocele Urologic Diseases |
Urination Disorders Urinary Bladder Diseases Urinary Incontinence Mandelic Acids Tolterodine |
Parasympatholytics Anti-Infective Agents Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Infective Agents, Urinary Renal Agents |
Cholinergic Agents Pharmacologic Actions Muscarinic Antagonists Urological Manifestations Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents |