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| Sponsor: | Depomed |
|---|---|
| Information provided by (Responsible Party): | Depomed |
| ClinicalTrials.gov Identifier: | NCT00636636 |
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 a day, is safe and effective for the treatment of postherpetic neuralgia.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuralgia,Postherpetic |
Drug: Gabapentin Extended Release tablets Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 452 |
| Study Start Date: | March 2008 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: G-ER
Gabapentin - Extended Release
|
Drug: Gabapentin Extended Release tablets
Once-Daily; 300 mg and 600 mg tablets
|
|
Placebo Comparator: Placebo
Sugar pill
|
Drug: Placebo
Once daily; 300 mg and 600 mg tablets
|
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).
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
Show 39 Study Locations
More Information
| Responsible Party: | Depomed |
| ClinicalTrials.gov Identifier: | NCT00636636 History of Changes |
| Obsolete Identifiers: | NCT01465321 |
| Other Study ID Numbers: | 81-0062 |
| Study First Received: | February 21, 2008 |
| Results First Received: | October 13, 2011 |
| Last Updated: | February 21, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
|
Postherpetic Neuralgia (PHN), shingles |
|
Neuralgia Neuralgia, Postherpetic Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Gabapentin Gamma-Aminobutyric Acid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents |