Effectiveness of Duloxetine in the Treatment of Stress Urinary Incontinence(Uncontrolled Leakage of Urine)

NCT00190827 | Completed Phase 3

• 2 other identifiers: 6195F1J-MC-SBBR
• Study Type: interventional
• Target: 500
• Locations: 8 countries
• Sites: 8

Brief Summary

The study evaluates the effectiveness of duloxetine in reducing urinary incontinence occurrences in women due to physical stress(e.g. stomach pressure on bladder). Incontinence is the inability to control bladder function with leakage of urine.

Conditions

Urinary Incontinence, Stress

Outcome Measures

Primary Outcomes (2)

• Compare duloxetine 40 mg BID with placebo in the reduction of incontinence episode frequency(IEF). Study visits occur every two weeks in therapy phase.

• Evaluate the effects of different regimens of dose escalation and tapering effects on incidence of most prevalent adverse events.

Secondary Outcomes (2)

• Assessment of overall patient safety.

• Reduction of IEFs using standardized instruments.

Interventions

duloxetine DRUG

placebo DRUG

Eligibility Criteria

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

You may qualify if:

• female outpatients \> or = 18 years of age
• experience episodes of stress urinary incontinence
• must have an educational level and degree of understanding English
• are free of urinary tract infections
• can use the toilet independently

You may not qualify if:

• any in or outpatient surgery in the last six months
• suffer from severe constipation
• extension of any internal organs beyond vaginal opening
• currently breastfeeding
• any nervous diseases affecting normal urinary function

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Boehringer Ingelheim: collaborator

Study Sites (8)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY(1-877-285-4559 OR 1-317-615-4559) Mon-Fri from 9am to 5pm Eastern time(UTC/GMT - 5 hours, EST) or speak with your personal physician

Rio de Janeiro, 20551-030, Brazil

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY(1-877-285-4559 or 1-317-615-4559) Mon-Fri from 9am to 5pm Eastern time(UTC/GMT - 5 hours, EST) or speak with your personal physician

Québec, Quebec, Quebec G1S 2L6, Canada

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY(1-877-285-4559 OR 1-317-615-4559) Mon-Fri from 9am to 5pm Eastern time(UTC/GMT - 5 hours, EST) or speak with your personal physician

Paris, 75651, France

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY(1-877-285-4559 OR 1-317-615-4559) Mon-Fri from 9am to 5pm Eastern time(UTC/GMT - 5 hours, EST) or speak with your personal physician

Mainz, 55131, Germany

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY(1-877-285-4559 OR 1-317-615-4559) Mon-Fri from 9am to 5pm Eastern time(UTC/GMT - 5 hours, EST) or speak with your personal physician

Torino, 10133, Italy

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY(1-877-285-4559 OR 1-317-615-4559) Mon-Fri from 9am to 5pm Eastern time(UTC/GMT - 5 hours, EST) or speak with your personal physician

Mexico City, 6700, Mexico

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY(1-877-285-4559 OR 1-317-615-4559) Mon-Fri from 9am to 5pm Eastern time(UTC/GMT - 5 hours, EST) or speak with your personal physician

San Juan, PR 00912, Puerto Rico

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY(1-877-285-4559 OR 1-317-615-4559) Mon-Fri from 9am to 5pm Eastern time(UTC/GMT - 5 hours, EST) or speak with your personal physician

Barcelona, 8036, Spain

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Call 1-877-CTLILLY(1-877-285-4559 or 1-317-615-4559) Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: September 1, 2003
• Study Completion: May 1, 2006
• Last Updated: January 26, 2007

Record last verified: 2007-01

Locations

BR (1); CA (1); FR (1); PR (1); DE (1); ES (1); IT (1); ME (1)