Trospium Chloride XR in Obese Female Patients With Overactive Bladder

Verified by: Allergan, June 2011
First Received: July 1, 2009 | Last Updated: June 7, 2011 | Phase: Phase 4 | Start Date: July 2009
Overall Status: Recruiting | Estimated Enrollment: 100
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This study evaluates the effectiveness of trospium XR in obese female patients with overactive bladder. The study will have a 2-week placebo run-in followed by randomization to trospium XR or placebo. The study will assess the change from baseline in urinary frequency, urgency, and incontinence for trospium XR versus a placebo-pill. The study will be of 14 weeks duration...

Brief Summary

This study evaluates the effectiveness of trospium XR in obese female patients with overactive bladder. The study will have a 2-week placebo run-in followed by randomization to trospium XR or placebo. The study will assess the change from baseline in urinary frequency, urgency, and incontinence for trospium XR versus a placebo-pill. The study will be of 14 weeks duration.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: October 2011

Intervention(s) in this Clinical Trial

  • Drug: Trospium Chloride, Extended Release
    • Placebo capsule taken once daily for 2 weeks followed by trospium XR 60 mg capsule taken orally once daily in the morning on an empty stomach 1 hour before a meal with a cup of water
  • Drug: placebo
    • Placebo capsule taken orally for 2 weeks once daily in the morning on an empty stomach 1 hour before meal followed by an additional 12 weeks.

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • trospium XR 60 mg
  • Placebo Comparator: 2
    • placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Median % change from baseline in the Urinary Urgency Incontinence
    • Time Frame: Week 14
      Safety Issue?: No

Secondary Measures

  • Mean % change from baseline in urgency severity associated with toilet voids
    • Time Frame: Week 14
      Safety Issue?: No
  • Mean % change from baseline in voided volume
    • Time Frame: Week 14
      Safety Issue?: No
  • Mean % change from baseline in OAB-Symptom Composite Score
    • Time Frame: Week 14
      Safety Issue?: No
  • Mean % change from baseline in percentage of patients continent
    • Time Frame: Week 14
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • OAB syndrome with Urgency, Urinary frequency and Urgency urinary incontinence
  • Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit).
  • Obese

Exclusion Criteria:

  • Chronic kidney failure
  • Abdominal bypass surgery for obesity
  • Moderate or severe memory impairment
  • Uncontrolled narrow angle glaucoma
  • Uncontrolled systemic disease
  • Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), or similar drugs for dementia

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Allergan Industry

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Allergan  

Overall Contact: Allergan Inc  clinicaltrials@allergan.com

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00932022

Study ID Number: MA-SXR-09-003

ClinicalTrials.gov Identifier: NCT00932022

Health Authority: United States: Institutional Review Board

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