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Sponsored by: |
Depomed |
---|---|
Information provided by: | Depomed |
ClinicalTrials.gov Identifier: | NCT00636636 |
Gabapentin and pregabalin are treatments for some types of neuropathic pain, including postherpetic neuralgia (PHN). However, these treatments usually need to be taken 3 times a day for effective pain control. The purpose of this study is to determine whether a new gabapentin tablet, which only needs to be taken once a day, is safe and effective for the treatment of postherpetic neuralgia.
Condition | Intervention | Phase |
---|---|---|
Neuralgia,Postherpetic |
Drug: Gabapentin Extended Release tablets |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients With Postherpetic Neuralgia |
Estimated Enrollment: | 450 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
2: Experimental |
Drug: Gabapentin Extended Release tablets
Once-Daily
|
The primary study objective is to assess the relative efficacy of G-ER dosed once daily (1800 mg following the evening meal), versus placebo in reducing the mean daily pain score from the baseline week to the end of the efficacy treatment period (Treatment Week 10) in patients with PHN.
Secondary efficacy measures will include changes from baseline in mean weekly sleep interference scores, Short-Form McGill Pain Questionnaire (SF-MPQ), the Neuropathic Pain Scale (NPS), Brief Pain Inventory (BPI), Patient Global Impression of Change (PGIC), and Investigator-Rated Clinical Global Impression of Change (CGIC).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jackie Givens | 512-292-9474 | Jackie.Givens@austin.ppdi.com |
Responsible Party: | Depomed, Inc ( Michelle Heritier ) |
Study ID Numbers: | 81-0062 |
Study First Received: | February 21, 2008 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00636636 History of Changes |
Health Authority: | United States: Institutional Review Board |
Postherpetic Neuralgia (PHN), shingles |
Herpes Zoster Neuralgia, Postherpetic Excitatory Amino Acids Neurotransmitter Agents Tranquilizing Agents Neuralgia Gabapentin Psychotropic Drugs Central Nervous System Depressants Calcium Channel Blockers Pain |
Cardiovascular Agents Antimanic Agents Signs and Symptoms Calcium, Dietary Neuromuscular Diseases Peripheral Nervous System Diseases Neurologic Manifestations Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Anticonvulsants |
Neuralgia, Postherpetic Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gabapentin Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Pain Membrane Transport Modulators Signs and Symptoms Neuromuscular Diseases Sensory System Agents |
Therapeutic Uses Analgesics Excitatory Amino Acid Antagonists Tranquilizing Agents Neuralgia Nervous System Diseases Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Pharmacologic Actions Peripheral Nervous System Diseases Neurologic Manifestations Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |