Trospium Chloride XR in Obese Female Patients With Overactive Bladder

NCT ID: NCT00932022

Last Updated: 2013-01-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Overactive Bladder Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Trospium Chloride, Extended Release (XR)

Intervention Type DRUG

Trospium chloride extended release 60 mg capsule taken orally once daily for 12 weeks.

placebo

Intervention Type OTHER

Placebo capsule taken orally once daily for either 2 weeks or 14 weeks.

placebo

Placebo capsule taken orally once daily for 14 weeks.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Placebo capsule taken orally once daily for either 2 weeks or 14 weeks.

Interventions

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Trospium Chloride, Extended Release (XR)

Trospium chloride extended release 60 mg capsule taken orally once daily for 12 weeks.

Intervention Type DRUG

placebo

Placebo capsule taken orally once daily for either 2 weeks or 14 weeks.

Intervention Type OTHER

Other Intervention Names

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Sanctura XR™ 60 mg

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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La Mesa, California, United States

Site Status

Countries

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United States

Other Identifiers

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Sanctura XR obesity OAB Trial

Identifier Type: OTHER

Identifier Source: secondary_id

MA-SXR-09-003

Identifier Type: -

Identifier Source: org_study_id

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