Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00004082

Trial Description

start of 1:1-Block title

Title

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.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004082
  •   2012/08/24
  •   2005/10/24
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT00244296  (ClinicalTrials.gov)
  •   8672  (Eli Lilly and Company)
  •   F1J-MC-SBCM 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Urinary Incontinence, Stress
  •   R32 -  Unspecified urinary incontinence
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: Duloxetine hydrochloride
  •   Drug: placebo
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   [---]*
  •   [---]*
  •   Treatment
  •   Parallel
  •   IV
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- 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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- 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
- Responder analysis based on percent change in IEF
- Patient's rating of improvement using the PGI-I
- Compare efficacy of duloxetine 40 mg twice daily with that of placebo as measured by the percent change in IEF using in the SUI and MUI subgroups
- To assess the impact of treatment with duloxetine 40 mg twice daily and placebo on the development of suicidal ideation.
- Assess the impact of treatment with duloxetine 40 mg twice daily and placebo in cognition.
- Assess the impact of treatment with duloxetine 40 mg twice daily and placebo as measured by changes in BDI-II.
- To compare the safety of duloxetine with placebo based on changes in vital signs, clinical lab values, occurrence and duration of adverse events and premature discontinuation of study due to adverse events.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   France
  •   Germany
  •   Netherlands
  •   South Africa
  •   Spain
  •   Sweden
  •   Switzerland
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2005/10/31
  •   276
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   65   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- 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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Eli Lilly and Company
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Boehringer Ingelheim
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Eli Lilly and Company
    • 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) 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Eli Lilly and Company
    • 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) 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.