Journal of Drugs in Dermatology - Phase III clinical trial for Gabapentin GR
Depomed, Inc, recently announced that it has completed a protocol for a Phase III clinical trial for Gabapentin GR extended release tablets for the treatment of postherpetic neuralgia. Enrollment for this randomized, double-blind, placebo-controlled study will begin soon. The study will include 400 patients with postherpectic neuralgia and will compare Gabapentin GR at a dose of 1800 mg BID to placebo and Gabapentin GR at a dose of 1800 mg QD to placebo. This multicenter study’s primary endpoint will be a reduction in pain score from baseline as measured by the numerical rating system known as the Likert pain scale. In addition, endpoints such as ability to sleep will be assessed. All patients will be in treatment for 8 weeks.
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Several months ago, the results from the Phase II trial of Gabapentin GR were reported to demonstrate statistically significant reduction in Likert pain scores. Apart from being shorter than the Phase III protocol, the Phase II trial was similar in structure. No serious adverse effects were reported and the most common non-serious adverse effect was dizziness.
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