Safety of Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy

Viatris

Status and phase: Completed; Phase 4

Conditions: Diabetic Peripheral Neuropathy

Treatments: Drug: Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00159731

A0081036

Details and patient eligibility

About

The purpose of this study is to 1) provide continued pregabalin treatment for 6 additional months to patients who have taken part in the placebo controlled study A0081060; and 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day)

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: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)