Open Label Phase III Duloxetine Study for Stress Urinary Incontinence
This study has been completed.
Sponsor:
Eli Lilly and Company
Collaborator:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191204
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
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Purpose
The purpose of this study is to monitor the long term safety of duloxetine in the treatment of stress urinary incontinence.
| Condition | Intervention | Phase |
|---|---|---|
|
Urinary Incontinence Stress |
Drug: Duloxetine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Long Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- The primary objective of this study is to generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence.
Secondary Outcome Measures:
- The secondary objective of this study is to collect data to demonstrate the maintenance of effect of duloxetine on patients quality of life, measured by Patient Impression of Improvement questionnaire.
| Estimated Enrollment: | 363 |
| Study Start Date: | September 2001 |
| Estimated Study Completion Date: | May 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Female out patients
- Are ambulatory and are able to use a toilet independently and without difficulty.
Exclusion Criteria:
- Use of monoamine oxidase inhibitors (MAOIs)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191204
Locations
| United Kingdom | |
| 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. | |
| Peterborough, United Kingdom, PE3 6JG | |
Sponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) OR 1-317-615-4559 Mon - Fri 9am - 5pm Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00191204 History of Changes |
| Other Study ID Numbers: | 5309, F1J-MC-SBBM |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 24, 2007 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013