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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00346034 |
The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081100 and who wish to receive open-label pregabalin therapy.
Condition | Intervention | Phase |
---|---|---|
Fibromyalgia |
Drug: Pregabalin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A 12 Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia |
Enrollment: | 357 |
Study Start Date: | December 2006 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Pregabalin
150 to 600mg/day
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trials Disclosure Group ) |
Study ID Numbers: | A0081101 |
Study First Received: | June 28, 2006 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00346034 |
Health Authority: | United States: Food and Drug Administration |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Pregabalin Pain Rheumatic Diseases |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases Peripheral Nervous System Agents |
Analgesics Central Nervous System Agents Anticonvulsants Pharmacologic Actions |