Efficacy and Safety Stress Urinary Incontinence Study - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00475358

Purpose

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.

Condition	Intervention	Phase
Urinary Incontinence, Stress	Drug: Duloxetine Drug: Placebo	Phase III

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Duloxetine Compared With Placebo in Subjects With Stress Urinary Incontinence

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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 Outcome Measures:

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).

Estimated Enrollment:	120
Study Start Date:	April 2003
Study Completion Date:	February 2005

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475358

Locations

Taiwan
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.
Tao-Yuan, Taiwan

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Study ID Numbers:	6231, F1J-MC-SBBT
Study First Received:	May 16, 2007
Last Updated:	May 16, 2007
ClinicalTrials.gov Identifier:	NCT00475358
Health Authority:	Taiwan: Institutional Review Board; United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Dopamine
Urinary Incontinence, Stress
Urologic Diseases
Urination Disorders

Stress
Urinary Incontinence
Serotonin
Duloxetine

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors

Pharmacologic Actions
Urological Manifestations
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009