Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.450 enrolled

Overview

To evaluate the efficacy and safety of pregabalin administered twice a day compared to placebo in reducing pain in subjects with painful diabetic peripheral neuropathy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

450

Conditions

Diabetic Neuropathies

Interventions

pregabalinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males or females at least 18 years of age, of any ethnic origin * Type 1 or 2 diabetes mellitus * Pain score greater than or equal to 4 on the 11-point numeric pain rating scale Exclusion Criteria: * Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain. * Presence of severe pain associated with conditions other than diabetic peripheral neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.

Locations (54)

Outcomes

Primary Outcomes

The primary efficacy parameter is the endpoint End of Week 12 weekly mean pain score derived from the pain diary.

Secondary Outcomes

End of Week 12 responder rates, Brief Pain Inventory - short form, sleep interference scores, Medical Outcome Study - Sleep Scale, Hospital Anxiety and Depression Scale, Patient Global Impression of Change, Neuropathic Pain Inventory Symptom Inventory.

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Tuscaloosa, Alabama, United States

Pfizer Investigational Site

Phoenix, Arizona, United States

Pfizer Investigational Site

Little Rock, Arkansas, United States

Pfizer Investigational Site

La Mesa, California, United States

Pfizer Investigational Site

Los Gatos, California, United States

Pfizer Investigational Site

Northridge, California, United States

Pfizer Investigational Site

Tustin, California, United States

Pfizer Investigational Site

Walnut Creek, California, United States

Pfizer Investigational Site

Boulder, Colorado, United States

Pfizer Investigational Site

Wheat Ridge, Colorado, United States

...and 44 more locations