Trospium Chloride XR in Obese Female Patients With Overactive Bladder

December 14, 2012 updated by: Allergan
This study evaluated the effectiveness of trospium chloride extended release (XR) in obese female patients with overactive bladder (OAB). Patients received either placebo and trospium chloride XR or placebo only. The study assessed the change from baseline in urinary frequency, urgency, and incontinence for trospium chloride XR versus a placebo-pill. The study was 14 weeks in duration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: trospium chloride XR 60 mg
Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
Drug: Trospium Chloride, Extended Release (XR)
Trospium chloride extended release 60 mg capsule taken orally once daily for 12 weeks.
Other Names:
  • Sanctura XR™ 60 mg
Other: placebo
Placebo capsule taken orally once daily for either 2 weeks or 14 weeks.
Placebo Comparator: placebo
Placebo capsule taken orally once daily for 14 weeks.
Other: placebo
Placebo capsule taken orally once daily for either 2 weeks or 14 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Urinary Urgency Incontinence (UUI)
Time Frame: Baseline (Week 2), Week 14
Patients recorded information about UUI (accidental leakage, urgency associated with void and urgency severity) in a 3-day diary at Baseline (Week 2) and Week 14. The daily average episodes of UUI was the sum of all UUI episodes over valid diary days during the 3-day diary period divided by the valid number of diary days with at least one valid bladder entry. The percent change from baseline was calculated as (Mean UUI at Week 14- Mean UUI at Week 2)/ Mean UUI at Week 2 X 100. A negative number percent change from baseline indicated an improvement.
Baseline (Week 2), Week 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Urgency Severity Associated With Toilet Voids
Time Frame: Baseline (Week 2), Week 14
Due to lack of evaluable data, analysis for this outcome measure was not performed.
Baseline (Week 2), Week 14
Percent Change From Baseline in Voided Volume
Time Frame: Baseline (Week 2), Week 14
Due to lack of evaluable data, analysis for this outcome measure was not performed.
Baseline (Week 2), Week 14
Percent Change From Baseline in Over Active Bladder (OAB)-Symptom Composite Score
Time Frame: Baseline (Week 2), Week 14
Due to lack of evaluable data, analysis for this outcome measure was not performed.
Baseline (Week 2), Week 14
Percent Change From Baseline in Percentage of Patients Continent
Time Frame: Baseline (Week 2), Week 14
Due to lack of evaluable data, analysis for this outcome measure was not performed.
Baseline (Week 2), Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

July 1, 2009

First Submitted That Met QC Criteria

July 1, 2009

First Posted (Estimate)

July 2, 2009

Study Record Updates

Last Update Posted (Estimate)

January 21, 2013

Last Update Submitted That Met QC Criteria

December 14, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-SXR-09-003
  • Sanctura XR obesity OAB Trial (Other Identifier: Allergan)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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