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Sponsored by: |
Eli Lilly and Company |
Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00475696 |
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.
Condition | Intervention | Phase |
Urinary Incontinence |
Drug: Duloxetine |
Phase II |
MedlinePlus related topics: | Urinary Incontinence |
ChemIDplus related topics: | Duloxetine Duloxetine hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Bladder Overactivity |
Estimated Enrollment: | 300 |
Study Start Date: | November 2002 |
Study Completion Date: | March 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Patients must have predominant symptoms of bladder overactivity defined as meeting both of the following criteria:
Exclusion Criteria:
Have any of the following:
United States, Indiana | |||||
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. | |||||
Indianapolis, Indiana, United States | |||||
Australia, Queensland | |||||
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, Queensland, Australia | |||||
Canada, Ontario | |||||
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. | |||||
North York, Ontario, Canada |
Eli Lilly and Company |
Study Director: | 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 |
Lilly Clinical Trial Registry 
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Study ID Numbers: | 6984, F1J-MC-SBBX |
First Received: | May 16, 2007 |
Last Updated: | May 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00475696 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; Canada: Health Canada; United States: Food and Drug Administration |
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