Overview

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

Status:
Completed
Trial end date:
2008-02-01
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Treatments:
Pregabalin
Criteria
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.