NCT00190814

Brief Summary

The purpose of the study is to evaluate the effectiveness of duloxetine in reducing urinary incontinence(leakage of urine)occurrences in women due to physical stress and leakage that occurs during a strong need(urge) to urinate.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2003

Typical duration for phase_3

Geographic Reach
3 countries

3 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

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

January 26, 2007

Status Verified

January 1, 2007

First QC Date

September 12, 2005

Last Update Submit

January 24, 2007

Conditions

Urinary Incontinence, Stress

Outcome Measures

Primary Outcomes (1)

  • The study purpose is to assess the efficacy of duloxetine 40 mg BID for up to 8 weeks in women with mixed urinary incontinence(MUI) compared with placebo as measured by: the change in total incontinence episode frequency(IEF) from baseline to endpoint.

Secondary Outcomes (2)

  • Additional assessments of incontinence episode frequency using various standardized instruments will be performed.

  • To monitor the safety of duloxetine based on clinical laboratory values and the occurrence of treatment-emergent adverse events.

Interventions

duloxetineDRUG
placeboDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female outpatients greater than or equal to 18 years of age.
  • experience episodes of urinary incontinence based on diagnostic criteria of at least 4 episodes a week with symptoms for a minimum of three months prior to start of study.
  • have an educational level and degree of understanding English.
  • are free of urinary tract infections.
  • have a discreet episodes of incontinence(i.e. dry between episodes and do not continuously leak.)

You may not qualify if:

  • have received treatment for incontinence within the last 5 years.
  • suffer from severe constipation.
  • currently nursing or breast feeding.
  • any nervous system disease that would affect normal urinary function.
  • any extension of internal organs beyond the vaginal opening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY(1-877-285-4559, 1-317-615-4559), Monday-Friday, 9 am to 5 pm Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician

Baltimore, Maryland, 21204, United States

Location

For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY(1-877-285-4559, 1-317-615-4559), Monday-Friday, 9 am to 5 pm Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician

London, Ontario, N6A 4L2, Canada

Location

For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY(1-877-285-4559, 1-317-615-4559), Monday-Friday, 9 am to 5 pm Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician

London, W2 1NY, United Kingdom

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) Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

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

September 12, 2005

First Posted

September 19, 2005

Study Start

September 1, 2003

Study Completion

May 1, 2006

Last Updated

January 26, 2007

Record last verified: 2007-01

Locations

GB(1)CA(1)US(1)