Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy

Viatris

Status and phase: Completed; Phase 3

Conditions: Diabetic Neuropathy, Painful

Treatments: Drug: pregabalin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00553475

A0081163

Details and patient eligibility

About

To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy.

Enrollment: 314 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Visual Analogue Scale (VAS) of pain is higher than 40 mm.
• Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year

Exclusion criteria

• Malignancy within the past 2 years.
• Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathy pain

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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314 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: placebo

Pregabalin 300 mg/day

Experimental group

Treatment:

Drug: pregabalin

Drug: pregabalin

Pregabalin 600 mg/day

Experimental group

Treatment:

Drug: pregabalin

Drug: pregabalin