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news.Depomed has dosed the first patient in a new pivotal Phase III clinical trial designed to evaluate the safety and efficacy of Gabapentin GR for the treatment of postherpetic neuralgia.
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The randomized, double-blind, placebo-controlled Phase III clinical trial will enroll approximately 450 patients with postherpetic neuralgia (PHN). Patients will be randomized into two treatment groups: 1800mg Gabapentin GR once-daily or placebo.
The primary objective of the study is to assess the efficacy of Gabapentin GR in reducing the pain associated with PHN, measured from baseline pain scores to the end of a ten-week stable treatment period on the basis of the Likert pain scale. Secondary objectives include an assessment of changes from baseline in sleep interference, and additional patient and clinician assessments of pain and quality of life.
Carl Pelzel, president and CEO of Depomed, said: “We are excited to move forward with this Phase III trial, and are encouraged by the interest from potential development and marketing partners for this Gabapentin GR program in neuropathic pain. We believe that the changes to this new protocol in this study will significantly increase our chances for success.”