Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain

Viatris

Status and phase: Completed; Phase 3

Conditions: Painful Diabetic Peripheral Neuropathy

Treatments: Drug: pregabalin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01455415

2011-002743-10 (EudraCT Number)

A0081268

Details and patient eligibility

About

This study is to test the effectiveness of pregabalin in treating nerve pain caused by diabetes. The suitable subjects will be patients who also use an non-steroid anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.

Enrollment: 306 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 or 2 diabetes with painful neuropathy
• Currently treated with one NSAID (including COX 2 inhibitors) for a co morbid pain condition with a regular dose
• Meet pre-defined level of pain severity at entrance

Exclusion criteria

• History of failed pregabalin treatment due to lack of efficacy at therapeutic dose
• Participated in a previous or ongoing pregabalin clinical trial
• Neurologic disorders unrelated to diabetic neuropathy that may confound the assessment of distal neuropathic pain

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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306 participants in 2 patient groups, including a placebo group

1: Pregabalin

Experimental group

Treatment:

Drug: pregabalin

2: Placebo

Placebo Comparator group

Treatment:

Drug: placebo