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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00190567
Other study ID # 2595
Secondary ID F1J-MC-SBAB
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated January 24, 2007
Start date October 2001
Est. completion date April 2006

Study information

Verified date January 2007
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Double-blind placebo-controlled study of the biomechanical effects of duloxetine compared with placebo in the treatment of women with pure genuine stress incontinence


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Female

- Between 18 and 75 years of age

- Diagnosis of GSI

- Have discrete episodes of incontinence

Exclusion Criteria:

- Positive urine culture at visit 1

- Use of MAOI

- Have had continence or urethral surgery

- Use of anti-incontinence device, vaginal pessaries or medications for the treatment of urinary incontinence

- Began pelvic floor muscle exercises within 6 months prior to study entry.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
duloxetine

Placebo


Locations

Country Name City State
United States For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5hours, EST), or speak with your personal physician Indianapolis Indiana

Sponsors (2)

Lead Sponsor Collaborator
Eli Lilly and Company Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compare the effects of duloxetine with placebo in women with urodynamically proved genuine stress incontinence(GSI)on vesical Valsalva leak point pressure
Secondary Compare the effects of duloxetine with that of placebo on measures of bladder emptying phase function derived from
Secondary non-instrumented and instrumented uroflowmetry studies
Secondary Percent change in Incontinent Episode Frequency (IEF) from baseline to endpoint
Secondary Subject-perceived improvement in their GSI as measured by the Patient Global Impressions-Improvement (PGI-I) questionnaire at endpoint
Secondary Compare duloxetine responders with duloxetine non-responders with respect to:
Secondary Baseline measures of urethral function
Secondary Outcome measures of urethral function
Secondary Outcome measures of emptying function
Secondary Vital signs, laboratory values and the occurrence of treatment-emergent adverse events
Secondary In the open-label extension:
Secondary Determine the effects of duloxetine six to seven months after initiation on measures of urethral function
Secondary Collect long-term data on the maintenance of effect of duloxetine in the treatment of GSI as measured by IEF, PGI-I, vital signs, laboratory values and the occurrence of treatment-emergent adverse events.
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