Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)

Viatris

Status and phase: Completed; Phase 3

Conditions: Diabetic Peripheral Neuropathy

Treatments: Drug: Pregabalin; Other: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01474772

A0081269

2011-003266-32 (EudraCT Number)

Details and patient eligibility

About

The intent of this study is to treat subjects with painful Diabetic Peripheral Neuropathy (DPN) who also have pain on walking and to determine whether or not pregabalin demonstrates improvement relative to placebo on the following: reducing DPN pain, reducing pain on walking, and providing other benefits associated with daily activities and quality of life.

Enrollment: 217 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women who are at least 18 years old.
• Diagnosis of painful diabetic peripheral neuropathy.
• Pain on walking.

Exclusion criteria

• Inability to walk 50 feet on a flat surface.
• Pain on walking due to conditions other than diabetic peripheral neuropathy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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217 participants in 2 patient groups, including a placebo group

Pregabain

Experimental group

Treatment:

Drug: Pregabalin

Placebo

Placebo Comparator group

Treatment:

Other: placebo