Efficacy and Safety Stress Urinary Incontinence Study
Efficacy and Safety of Duloxetine Compared With Placebo in Subjects With Stress Urinary Incontinence
2 other identifiers
interventional
120
1 country
1
Brief Summary
Study F1J-MC-SBBT will examine the effect of duloxetine treatment in women with SUI. The inclusion and exclusion criteria of this Phase 3 study will ensure that all subjects have a clinical diagnosis of SUI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2003
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 16, 2007
CompletedFirst Posted
Study publicly available on registry
May 21, 2007
CompletedMay 21, 2007
May 1, 2007
May 16, 2007
May 16, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
To assess efficacy of duloxetine 80 mg/day for 8 weeks in women with stress urinary incontinence (SUI) compared with placebo as measured by percent change in incontinence episode frequency from baseline.
Secondary Outcomes (3)
To compare the efficacy of duloxetine with that of placebo as measured by the change in the disease-specific quality of life instrument (I QOL) scores from baseline to endpoint.
To compare the efficacy of duloxetine with that of placebo in subject perceived improvement in SUI as measured by the Patient's Global Impressions of Improvement (PGI I) questionnaire.
To compare the safety of duloxetine with that of placebo in the treatment of SUI based on vital signs, laboratory values, and the occurrence of treatment-emergent adverse events (TEAEs).
Interventions
Eligibility Criteria
You may qualify if:
- Are greater than 20 years of age.
- Are female outpatients.
- Present with SUI based on the disease diagnostic criteria, average at least one incontinent episode per day on the screening diary, and have had symptoms of SUI for a minimum of 3 months prior to study entry.
- Are women of non-childbearing potential by reason of hysterectomy, other surgery, or natural menopause, or are women of childbearing potential who test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a medically accepted means of contraception (for example, intrauterine device \[IUD\], oral or injectable contraceptives, implant, barrier device, sterilization, abstinence, or sex with a vasectomized male partner) for the duration of the study. Women using oral contraceptives or hormone replacement therapy must have a stable dose and regimen for greater than or equal to 3 months prior to entry into the study.
- Have no language barrier, agree to comply with the requirements of the protocol, and sign a written informed consent document prior to entry into the study.
You may not qualify if:
- Suffer from severe constipation (for example, have impacted rectum at time of physical examination despite recent evacuation).
- Has a physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.
- Are on a medication regimen (including diuretics) for which dose and/or frequency has not been stable for at least 12 weeks prior to randomization, or is anticipated to change during the course of the study.
- Have had any major inpatient surgery within 3 months prior to study entry.
- Have current diagnosis of any of the following conditions, disorders, or diseases of the genito-urinary tract: Ureteric, bladder, urethral, or rectal fistula
- Uncorrected congenital abnormality leading to urinary incontinence
- Detrusor instability or noncompliant bladder
- Adult enuresis
- Voiding difficulty (i.e., subject complains of difficulty emptying their bladder).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Taoyuan District, Taiwan
Related Publications (1)
Lin AT, Sun MJ, Tai HL, Chuang YC, Huang ST, Wang N, Zhao YD, Beyrer J, Wulster-Radcliffe M, Levine L, Chang C, Viktrup L. Duloxetine versus placebo for the treatment of women with stress predominant urinary incontinence in Taiwan: a double-blind, randomized, placebo-controlled trial. BMC Urol. 2008 Jan 25;8:2. doi: 10.1186/1471-2490-8-2.
PMID: 18221532DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
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
May 16, 2007
First Posted
May 21, 2007
Study Start
April 1, 2003
Study Completion
February 1, 2005
Last Updated
May 21, 2007
Record last verified: 2007-05