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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00570310 |
The purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain.
Condition | Intervention | Phase |
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Neuralgia, Postherpetic Diabetic Neuropathy Painful Small-Fiber Neuropathy Idiopathic Distal Sensory Polyneuropathy |
Drug: Comparator: pregabalin Drug: Comparator: Placebo (unspecified) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled, Enriched-Enrollment, Randomized Withdrawal Study to Evaluate an Optimal Methodology for Conducting Proof of Concept Trials in Patients With Chronic Neuropathic Pain Syndromes Using Pregabalin as a Test Drug |
Estimated Enrollment: | 120 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Patients in Group A will remain on pregabalin (up to 600 mg/day po) treatment for the entire double-blind period.
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Drug: Comparator: pregabalin
pregabalin (up to 600 mg/day po). Duration of Treatment: 6 Weeks
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B: Placebo Comparator
Patients in Group B will be treated with placebo.
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Drug: Comparator: Placebo (unspecified)
pregabalin Pbo (up to 600 mg/day po). Duration of Treatment: 6 Weeks
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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:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2007_650, 072 |
Study First Received: | December 7, 2007 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00570310 |
Health Authority: | United States: Food and Drug Administration |
Neuralgia, Postherpetic Diabetic Neuropathies Neuralgia Polyneuropathies Diabetes Mellitus Pregabalin Endocrine System Diseases |
Pain Signs and Symptoms Neuromuscular Diseases Peripheral Nervous System Diseases Neurologic Manifestations Endocrinopathy Diabetes Complications |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases Peripheral Nervous System Agents |
Analgesics Central Nervous System Agents Anticonvulsants Pharmacologic Actions |