Efficacy and Tolerability of DITROPAN XL (Oxybutynin Chloride) Versus DETROL LA (Tolterodine Tartrate) in Treatment of Overactive Bladder

This study has been completed.
Sponsor:
Information provided by:
Alza Corporation, DE, USA
ClinicalTrials.gov Identifier:
NCT00293839
First received: February 16, 2006
Last updated: December 7, 2010
Last verified: December 2010
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy and Tolerability of DITROPAN XL and DETROL LA in the Treatment of Overactive Bladder

Resource links provided by NLM:


Further study details as provided by Alza Corporation, DE, USA:

Primary Outcome Measures:
  • The number of weekly urge urinary incontinence (Urge-UI) episodes at week 12, adjusted for the baseline value

Secondary Outcome Measures:
  • The number of total urinary incontinence (Total-UI) episodes at week 12; Void frequency at week 12; Urge-UI ,Total-UI, and Void frequence at weeks 2, 4, and 8; tolerability of the treatments during the 12-week treatment phase.

Enrollment: 790
Study Completion Date: December 2002
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants who are able to differentiate urinary incontinence episodes associated with urgency from urinary incontinence episodes not associated with urgency
  • during the 7 day baseline period have 21 to 60 urge urinary incontinence (Urge-UI) episodes, a greater number of Urge-UI episodes than urinary incontinence not associated with urge, and an average of 10 or more voids per 24 hours
  • are in good general health as determined by medical history, physical examination (general, genital, pelvic, and rectal), laboratory tests and urinalysis
  • if taking antihypertension medication, must be on a stable dose
  • and if of child-bearing potential, practicing an acceptable method of birth control, and must have a negative pregnancy test at Visit 2 and Visit 3

Exclusion Criteria:

  • Participants with known, treatable genitourinary conditions (identified on history or on examination) that may cause incontinence (e.g., urinary tract infection, interstitial cystitis, urinary tract obstruction, urethral diverticulum, bladder tumor, bladder stone)
  • have given birth or have had pelvic, vaginal or bladder surgery less than 6 months before study enrollment
  • with a second post-void residual urine volume > 150 mL at the time of screening (determined by abdominal ultrasound)
  • with significant medical problems or other organ abnormality that places them at risk from participating in the study or at a significant risk of developing complete urinary retention
  • with significant impairment of the liver or kidneys as determined by laboratory assessments or hematuria (red blood cells in microscopic urinalysis)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293839

Sponsors and Collaborators
Alza Corporation, DE, USA
Investigators
Study Director: Alza Corporation Clinical Trial ALZA
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00293839     History of Changes
Other Study ID Numbers: CR004570
Study First Received: February 16, 2006
Last Updated: December 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Alza Corporation, DE, USA:
bladder
overactive

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Oxybutynin
Tolterodine
Mandelic Acids
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Renal Agents

ClinicalTrials.gov processed this record on April 21, 2014