Pregabalin Peripheral Neuropathic Pain Study

Viatris

Status and phase

Completed

Phase 3

Conditions

Diabetic Neuropathies

Neuralgia

Treatments

Drug: Placebo

Drug: pregabalin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00141219

A0081037

Details and patient eligibility

About

To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.

Enrollment

241 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of peripheral neuropathic pain syndrome, including diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), or post-traumatic neuropathic pain (including post-surgical), confirmed by a qualified pain specialist.
Subjects must have completed at least 4 daily pain diaries during the 7 days prior to Visit 2 and have an average pain score of ≥4 over the 7 days prior to Visit 2 (randomization).

Exclusion criteria

Neurologic disorders unrelated to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical), that may confuse or confound the assessment of neuropathic pain.
Presence of any severe pain associated with conditions other than DPN, PHN, or post-traumatic neuropathic pain (including post-surgical) that may confound the assessment or self evaluation of the pain due to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical).
Creatinine clearance < 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation in Appendix E). Maximum dose for subjects with creatinine clearance of 30 to 60 mL/min is 300 mg/day