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Trospium Chloride XR in Obese Female Patients With Overactive Bladder

Primary Purpose

Obesity, Overactive Bladder, Incontinence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Trospium Chloride, Extended Release (XR)
placebo
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

trospium chloride XR 60 mg

placebo

Arm Description

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.

Placebo capsule taken orally once daily for 14 weeks.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Urinary Urgency Incontinence (UUI)
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.

Secondary Outcome Measures

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

Full Information

First Posted
July 1, 2009
Last Updated
December 14, 2012
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00932022
Brief Title
Trospium Chloride XR in Obese Female Patients With Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overactive Bladder, Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
trospium chloride XR 60 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule taken orally once daily for 14 weeks.
Intervention Type
Drug
Intervention Name(s)
Trospium Chloride, Extended Release (XR)
Other Intervention Name(s)
Sanctura XR™ 60 mg
Intervention Description
Trospium chloride extended release 60 mg capsule taken orally once daily for 12 weeks.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Placebo capsule taken orally once daily for either 2 weeks or 14 weeks.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Urinary Urgency Incontinence (UUI)
Description
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.
Time Frame
Baseline (Week 2), Week 14
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Urgency Severity Associated With Toilet Voids
Description
Due to lack of evaluable data, analysis for this outcome measure was not performed.
Time Frame
Baseline (Week 2), Week 14
Title
Percent Change From Baseline in Voided Volume
Description
Due to lack of evaluable data, analysis for this outcome measure was not performed.
Time Frame
Baseline (Week 2), Week 14
Title
Percent Change From Baseline in Over Active Bladder (OAB)-Symptom Composite Score
Description
Due to lack of evaluable data, analysis for this outcome measure was not performed.
Time Frame
Baseline (Week 2), Week 14
Title
Percent Change From Baseline in Percentage of Patients Continent
Description
Due to lack of evaluable data, analysis for this outcome measure was not performed.
Time Frame
Baseline (Week 2), Week 14

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
La Mesa
State/Province
California
Country
United States

12. IPD Sharing Statement

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Trospium Chloride XR in Obese Female Patients With Overactive Bladder

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