NCT00244296|CompletedPhase 4

To Determine How Effective Duloxetine is in Treating Women 65 Years and Older With Symptoms of Stress Urinary Incontinence, or With a Combination of Stress Urinary Incontinence and Urge Urinary Incontinence Symptoms

A Double-Blind, Stratified, Randomised, Parallel, Placebo-Controlled, Multi-Centre Study to Assess the Efficacy and Safety of Duloxetine (20 mg Bid for 2 Weeks Escalating to 40 mg Bid) for up to 12 Weeks, Compared to Placebo, in Community-Dwelling Elderly Women > or = 65 Years of Age With Symptoms of Stress Urinary Incontinence or Stress-Predominant Mixed Urinary Incontinence.

Eli Lilly and Company ClinicalTrials.gov

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2 other identifiers

8672F1J-MC-SBCM

Study Type

interventional

Target

276

Locations

7 countries

Sites

Timeline

RegisteredOct 2005

StartedOct 2005

CompletionJan 2007

Brief Summary

The purpose of this study is to determine how effective duloxetine is in treating women who are 65 years of age or older with symptoms of stress urinary incontinence, or with a combination of stress urinary incontinence and urge urinary incontinence symptoms.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

276

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Oct 2005

Geographic Reach

7 countries

31 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

October 1, 2005

Completed

23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2005

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2005

Completed

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed

Last Updated

January 26, 2007

Status Verified

January 1, 2007

First QC Date

October 24, 2005

Last Update Submit

January 24, 2007

Conditions

Urinary Incontinence, Stress

Outcome Measures

Primary Outcomes (1)

Assess the efficacy of duloxetine for up to 12 weeks, compared to placebo, in community dwelling women > or = 65 years of age with symptoms of pure stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence

Secondary Outcomes (12)

Compare the efficacy of duloxetine 40 mg twice daily with that of placebo in the treatment of the symptoms of SUI and stress-predominant MUI as measured by:Absolute change in IEF
Change in mean time between voids
Percent change in the number of continence pads used per week
Change in the Incontinence Quality of Life total score and 3 sub-domain scores
Responder analysis based on the established within-treatment minimal clinically important difference established for the I-QOL
+7 more secondary outcomes

Interventions

Duloxetine hydrochlorideDRUG

placeboDRUG

Eligibility Criteria

Age65 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

You may qualify if:

female outpatient greater than or equal to 65 years of age
have symptoms of SUI or stress-predominant MUI for at least 3 consecutive months
have at least 7 incontinence episodes per week. For patients with MUI, at least 50% of the IEF must be due to stress.
is ambulatory and able to use a toilet independently and without difficulty

You may not qualify if:

at Visit 1 have a positive urine culture or a history of four or more urinary tract infections (UTIs) in the preceding year
have had continence surgery or received bladder neck bulking agent therapy within 3 months prior to study entry
began pelvic floor muscle exercises (for example, Kegel or biofeedback) within 3 months prior to study entry or at any time during the study.
have neurologic lesions or conditions (e.g. multiple sclerosis, spinal cord lesions or Parkinson's disease) or local lesions (e.g. bladder stones present or tumors) that affect the lower urinary tract.
intake of monoamine oxidase inhibitors (MAOIs) within 14 days prior to randomisation or at any time during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead
Boehringer Ingelheimcollaborator

Study Sites (31)

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.

Champcueil, France

Location

Limoges, France

Location

Nice, France

Location

Nîmes, France

Location

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

Paris, France

Location

Alzey, Germany

Location

Bad Ems, Germany

Location

Düsseldorf, Germany

Location

Karlsruhe, Germany

Location

Koblenz, Germany

Location

Leipzig, Germany

Location

Mühlacker, Germany

Location

Rheinstetten/Baden, Germany

Location

Vellmar, Germany

Location

Wiesloch, Germany

Location

Amsterdam, Netherlands

Location

Apeldoorn, Netherlands

Location

Nieuwegein, Netherlands

Location

Tilburg, Netherlands

Location

Zeist, Netherlands

Location

Johannesburg, South Africa

Location

Barcelona, Spain

Location

Castellon, Spain

Location

Santa Cruz de Tenerife, Spain

Location

Vigo, Spain

Location

Lund, Sweden

Location

Stockholm, Sweden

Location

Uppsala, Sweden

Location

Basel, Switzerland

Location

Riehen, Switzerland

Location

Zurich, Switzerland

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

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 DIRECTOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

October 24, 2005

First Posted

October 26, 2005

Study Start

October 1, 2005

Study Completion

January 1, 2007

Last Updated

January 26, 2007

Record last verified: 2007-01

Locations

DE(10)CH(3)FR(5)NL(5)ES(4)SE(3)ZA(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (31)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations