Efficacy and Safety of Duloxetine, Placebo and Pelvic Floor Muscle Training in Subjects With Stress Urinary Incontinence - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

January 24, 2007

Start Date ^ICMJE

January 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Effectiveness of combined duloxetine and PFMT with combined placebo and imitation PFMT in women with SUI as measured by percent change in Incontinence Episode Frequency from baseline to endpoint.
Effectiveness of combined duloxetine and PFMT with combined placebo and PFMT for up to 12 weeks in women with SUI as measured by percent change in Incontinence Episode Frequency from baseline to endpoint.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00190606 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incontinence Quality of Life scores from baseline to endpoint.
Patient Global Impression - Impression at endpoint.
Symptoms Frequency & Bothersomeness.
Percent change in weekly continence pad usage (CPAD) from baseline to endpoint.
Change in Patient Satisfaction Questionnaires -2 and -4 questionnaire scores from baseline to endpoint.
Percent change in daily CPAD from baseline to endpoint.
Compare safety of duloxetine with placebo based on vital signs , laboratory values and the occurrence of treatment-emergent adverse events.
Compare combined duloxetine and PFMT, combined duloxetine and imitation PFMT, combined placebo with PFMT and combined placebo and imitation PFMTwith respect to efficacy and to safety.
Compare the effect of duloxetine and placebo on patient compliance to PFMT and imitation PFMT regimes using a daly patient-generated log of completed contractions.
Generate long-term safety data (during open-label extension) on duloxetine in the treatment of women with SUI.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Duloxetine, Placebo and Pelvic Floor Muscle Training in Subjects With Stress Urinary Incontinence

Official Title ^ICMJE

Efficacy and Safety of Duloxetine Compared With Placebo,Pelvic Floor Muscle Training, and Combined Duloxetine/Pelvic Floor Muscle Training in Subjects With Moderate to Sever Stress Urinary Incontinence

Brief Summary

The study is a comparison of the efficacy and safety of duloxetine and pelvic floor muscle training with that of placebo in patients with moderate to severe stress urinary incontinence

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Urinary Stress Incontinence

Intervention ^ICMJE

Drug: Duloxetine
Procedure: Pelvic Floor Muscle Training (PFMT)
Procedure: Imitation PFMT
Drug: placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

April 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Female
Between 18 and 75 years of age
Confirmed pure genuine stress incontinence
Have discrete episodes of incontinence
Have pelvic organ prolapse of no greater than Stage II

Exclusion Criteria:

Positive urine culture at visit 1
Had formal PFMT with instruction
Use of MAOI or other excluded medications
Use of any anti-incontinence device, vaginal pessaries or any medication prescribed for the treatment of urinary incontinence

Gender

Female

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00190606

Responsible Party

Study ID Numbers ^ICMJE

2615, F1J-MC-SBAF

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Investigators ^ICMJE

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

January 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP