A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)

Viatris

Status and phase: Completed; Phase 4

Conditions: Diabetic Neuropathy, Painful

Treatments: Drug: pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00156078

A0081030

Details and patient eligibility

About

A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Type 1 or 2 diabetes mellitus.
• Diagnosis of painful DPN for at least 12 months but less than 5 years in duration.

Exclusion criteria

• Neurologic Disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
• Presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind