A Study to Assess the Efficacy, Safety and Tolerability of Pregabalin in Patients With Symptoms of Neuropathic Pain

Viatris

Status and phase: Completed; Phase 3

Conditions: Neuropathic Pain

Treatments: Drug: Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00301223

A0081081

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy, safety and tolerability for pregabalin using a flexible, optimized dose schedule compared to placebo in relieving the symptoms of neuropathic pain.

Enrollment: 309 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chinese outpatient of age 18 to 75
• At screening and baseline, a score of greater than 40 mm on the visual log scale of SF-MPQ

Exclusion criteria

• Neurologic disorders unrelated to neuropathic pain, which in the opinion of the investigator, might impair the assessment of pain
• Serum creatinine clearance greater than 60 ml/min

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind