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| Sponsor: | Depomed |
|---|---|
| Information provided by: | Depomed |
| ClinicalTrials.gov Identifier: | NCT00335933 |
Purpose
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 or twice 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, Placebo Control, Factorial 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: | 378 |
| Study Start Date: | May 2006 |
| Study Completion Date: | July 2007 |
The primary study objective is to assess the relative efficacy of G-ER dosed once daily (1800 mg following the evening meal) or twice daily (600 mg AM/1200 mg PM), 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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | 81-0045 |
| Study First Received: | June 8, 2006 |
| Last Updated: | August 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00335933 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Postherpetic Neuralgia (PHN) |
|
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 |