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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00475696




Registration number
NCT00475696
Ethics application status
Date submitted
16/05/2007
Date registered
21/05/2007
Date last updated
21/05/2007

Titles & IDs
Public title
Urge Incontinence Bladder Overactivity Study
Scientific title
Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Bladder Overactivity
Secondary ID [1] 0 0
F1J-MC-SBBX
Secondary ID [2] 0 0
6984
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Incontinence 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Duloxetine

Treatment: Drugs: Duloxetine


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To monitor the safety of duloxetine 80 mg/day-120 mg/day in women with bladder overactivity due to pure detrusor instability or sensory urgency.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
To assess the subject’s self-perceived improvement since starting study medication as measured by change from baseline on the following validated 7-point scale, Patient’s Global Impressions of Improvement scale (PGI-I).
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Are female outpatients.

- Are at least 18 years of age.

- Are ambulatory and able to use a toilet independently and without difficulty.

- Have no language or cognitive barriers, agree to comply with the requirements of the
protocol, and sign a written informed consent document prior to entry into the study.

- Are women of non-childbearing potential by reason of hysterectomy or natural
menopause, or are women of childbearing potential agreeing 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
3 months prior to the study.

- Have post-void residual (PVR) volume 100 mL within 15 minutes of a spontaneous void.

- Patients must have predominant symptoms of bladder overactivity defined as meeting
both of the following criteria:

1. bothersome urinary urgency (the sensation of the urgent need to void for fear of
leakage) for a minimum of 3 consecutive months prior to study entry, or urge
urinary incontinence (UUI; the involuntary loss of urine preceded by urgency) for
a minimum of 3 consecutive months prior to study entry

2. abnormal frequency of micturition (an average voiding interval of 2 hours or less
[2] during waking hours) as confirmed by at least two days of recording on the
screening dairy collected at Visit 1.

- Have UDS established DI or sensory urgency (determined at Visit 2).

- Have responded appropriately to all screening questions prior to Visit 1.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Use any medication other than duloxetine for urinary incontinence within 1 day prior
to starting study medication or at any time during the study.

- Use monoamine oxidase inhibitors (MAOIs) or other excluded medications within 14 days
prior to starting study medication or at any time during the study.

- Have any of the following:

- A significant arrhythmia despite antiarrhythmic medication, uncontrolled angina,
or a significant abnormality on ECG within 6 months prior to study entry that, in
the opinion of the investigator, requires investigation or intervention.

- Any active cardiac ischemic condition, including myocardial infarction within 6
months prior to study entry

- Uncontrolled or poorly controlled hypertension

- Active seizure disorder

- Unstable diabetes mellitus

- Spinal cord lesions, multiple sclerosis, or other neurological abnormalities that
affect the lower urinary tract

- History of severe allergies requiring emergency medical treatment or multiple
adverse drug reactions

- History of chronic lung disease associated with four (4) or more acute
exacerbations per year resulting in severe coughing

- Active or chronic hepatitis A, B, or C.

- Are pregnant, have been pregnant in the previous 6 months, or have not resumed normal
menstruation for 3 months prior to study entry due to breastfeeding.

- Are breastfeeding.

- Have received treatment within the last 30 days with a drug other than duloxetine that
has not received regulatory approval in any country for any indication at the time of
study entry.

- Have any condition, limitation, disease, or abnormal laboratory value that could, in
the judgment of the investigator, preclude evaluation of response to duloxetine.

- Are directly affiliated with the conduct of this study, or are immediate family of
someone directly affiliated with the conduct of this study (that is, Lilly employees,
investigators, site personnel, or their immediate families). Immediate family is
defined as a spouse, parent, child or sibling, whether biological or legally adopted.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
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. - Townsville
Recruitment postcode(s) [1] 0 0
- Townsville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Indiana
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Examine the efficacy and safety of duloxetine in subjects with symptoms of bladder
overactivity due to pure detrusor instability or sensory urgency. Subjects in study will be
permitted to escalate or de-escalate between 80 mg/day and 120 mg/day in consultation with
the investigator and based on their adverse events.
Trial website
https://clinicaltrials.gov/show/NCT00475696
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications