Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy

Viatris

Status and phase: Completed; Phase 4

Conditions: Diabetic Neuropathy, Painful

Treatments: Drug: Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00159679

A0081060

Details and patient eligibility

About

The purposes of this study are to: 1) find out if pregabalin relieves pain in subjects with painful diabetic peripheral neuropathy; 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day); and 3) find out if changes in nerve function happen during the study.

Enrollment: 167 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults with Type 1 or 2 diabetes
• Patients must have pain in their lower legs or feet due to painful diabetic neuropathy that has lasted for at least 3 months

Exclusion criteria

• Patients must not be in poor or unstable health.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind