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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00752505 |
The study is designed to assess if esreboxetine can improve the cognitive function of patients with fibromyalgia. Cognitive function is defined as the ability to concentrate, remember things and make decisions or problem solve. The study is also designed to assess if there is a difference in cognitive function between fibromyalgia patients and matched control subjects.
Condition | Intervention | Phase |
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Fibromyalgia |
Drug: Esreboxetine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Randomized Double-Blind Placebo-Controlled Crossover Study Assessing The Ability Of Esreboxetine (PNU-165442g) To Improve Cognitive Function In Fibromyalgia Patients. |
Estimated Enrollment: | 80 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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B: Experimental |
Drug: Esreboxetine
Tablet once daily either placebo, 4mg or 8mg per day. Subjects will be on active treatment for 4 weeks out of a total of 11 weeks in a crossover dosing
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A: Experimental |
Drug: Esreboxetine
Tablet once daily either placebo, 4mg or 8mg per day. Subjects will be on active treatment for 4 weeks out of a total of 11 weeks in a crossover dosing
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
United States, Michigan | |
Pfizer Investigational Site | Recruiting |
Bingham Farms, Michigan, United States, 48025 | |
United States, Oklahoma | |
Pfizer Investigational Site | Recruiting |
Oklahoma City, Oklahoma, United States, 73103 | |
United States, Texas | |
Pfizer Investigational Site | Recruiting |
Dallas, Texas, United States, 75231 | |
Pfizer Investigational Site | Recruiting |
Austin, Texas, United States, 78756 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A6061061 |
Study First Received: | September 12, 2008 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00752505 |
Health Authority: | United States: Food and Drug Administration |
Fibromyalgia |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Pain Rheumatic Diseases |
Nervous System Diseases |