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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00159679 |
The purposes of this study are to: 1) find out if pregabalin relieves pain in subjects with painful diabetic peripheral neuropathy; 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day); and 3) find out if changes in nerve function happen during the study.
Condition | Intervention | Phase |
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Diabetic Neuropathy, Painful |
Drug: Pregabalin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 13 Week, Double-Blind, Placebo-Controlled Phase 4 Trial of Pregabalin (CI-1008, 600 mg/Day) for Relief of Pain in Subjects With Painful Diabetic Peripheral Neuropathy |
Enrollment: | 167 |
Study Start Date: | September 2004 |
Study Completion Date: | October 2005 |
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: | A0081060 |
Study First Received: | September 8, 2005 |
Last Updated: | April 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00159679 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neuromuscular Diseases Diabetic Neuropathies Peripheral Nervous System Diseases Diabetes Mellitus Pregabalin Endocrine System Diseases |
Pain Peripheral Nervous System Agents Analgesics Endocrinopathy Anticonvulsants Diabetes Complications |
Diabetic Neuropathies Nervous System Diseases Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Pregabalin Pharmacologic Actions Neuromuscular Diseases |
Sensory System Agents Therapeutic Uses Peripheral Nervous System Diseases Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants Diabetes Complications |