Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy

Viatris

Status and phase: Completed; Phase 3

Conditions: Diabetic Neuropathy, Painful

Treatments: Drug: Placebo; Drug: pregabalin (Lyrica)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01057693

2009-017389-21 (EudraCT Number)

A0081242

Details and patient eligibility

About

Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.

Enrollment: 633 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have painful diabetic peripheral neuropathy and be receiving treatment for this condition.

Exclusion criteria

• Patients with other pain conditions cannot participate.

Trial design

633 participants in 2 patient groups, including a placebo group

pregabalin (Lyrica)

Experimental group

Treatment:

Drug: pregabalin (Lyrica)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo