- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00475696
Urge Incontinence Bladder Overactivity Study
May 16, 2007 updated by: Eli Lilly and Company
Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Bladder Overactivity
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.
Study Overview
Study Type
Interventional
Enrollment
300
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Queensland
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Townsville, Queensland, Australia
- 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.
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Ontario
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North York, Ontario, Canada
- 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.
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Indiana
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Indianapolis, Indiana, United States
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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:
- 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
- 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.
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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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).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2002
Study Completion (Actual)
March 1, 2005
Study Registration Dates
First Submitted
May 16, 2007
First Submitted That Met QC Criteria
May 16, 2007
First Posted (Estimate)
May 21, 2007
Study Record Updates
Last Update Posted (Estimate)
May 21, 2007
Last Update Submitted That Met QC Criteria
May 16, 2007
Last Verified
May 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urination Disorders
- Urinary Incontinence
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Duloxetine Hydrochloride
Other Study ID Numbers
- 6984
- F1J-MC-SBBX
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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