Efficacy Study Measuring the Impact of Pregabalin on Peripheral Neuropathic Pain.

A Randomized, Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Peripheral Neuropathic Pain

This study will measure the impact of treatment with pregabalin in adult men and women who have a diagnosis of peripheral neuropathic pain (pain caused by a primary lesion of the peripheral nervous system such as Diabetic peripheral Neuropathy and Postherpetic Neuralgia).

Inclusion Criteria:

• Subjects presenting a diagnosis of peripheral neuropathic pain, defined as pain caused by a lesion of the peripheral nervous system manifesting with sensory symptoms and signs, for at least 6 months at screening.
• At baseline, subjects must have completed at least 4 daily pain diaries and must have a mean weekly pain score equal or greater than 4.

Exclusion Criteria:

• Presence of any of the following diagnoses: Cervical or lumbo-sacral radiculopathy; Operated or non-operated chronic low back pain Carpal tunnel syndrome or any other entrapment-related neuropathic pain (defined as pain associated with focal nerve lesion produced by constriction or mechanical distortion of the nerve, within a fibrous or fibro-osseous tunnel, or by a fibrous band) ; Complex regional pain syndrome (type 1 and 2); Fibromyalgia.