Trospium Chloride XR in Obese Female Patients With Overactive Bladder

NCT00932022 | Completed Phase 4 Results

• 2 other identifiers: MA-SXR-09-003Sanctura XR obesity OAB Trial
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overactive Bladder; Incontinence

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Week 2), Week 14

Secondary Outcomes (4)

• Percent Change From Baseline in Urgency Severity Associated With Toilet Voids

  Baseline (Week 2), Week 14

• Percent Change From Baseline in Voided Volume

  Baseline (Week 2), Week 14

• Percent Change From Baseline in Over Active Bladder (OAB)-Symptom Composite Score

  Baseline (Week 2), Week 14

• Percent Change From Baseline in Percentage of Patients Continent

  Baseline (Week 2), Week 14

Study Arms (2)

trospium chloride XR 60 mg

EXPERIMENTAL

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); Other: placebo

placebo

PLACEBO COMPARATOR

Placebo capsule taken orally once daily for 14 weeks.

Other: placebo

Interventions

Trospium Chloride, Extended Release (XR) DRUG

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

Also known as: Sanctura XR™ 60 mg

trospium chloride XR 60 mg

placebo OTHER

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

placebo; trospium chloride XR 60 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

La Mesa, California, United States

Location

MeSH Terms

Conditions

Obesity; Urinary Bladder, Overactive

Interventions

trospium chloride

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations

Limitations and Caveats

Due to lack of evaluable data, analysis for the secondary outcome measures was not performed.

Results Point of Contact

• Title: Vice President Medical Affairs,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 2, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 21, 2013
• Results First Posted: January 21, 2013

Record last verified: 2012-12

Locations

US (1)