BMS-741672 for Diabetic Neuropathic Pain

Phase 2CompletedNCT00683423

Bristol-Myers Squibb50 enrolled

Overview

The purpose of the study is to determine whether BMS-741672 improves neuropathic pain in diabetic patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Neuropathic Pain

Interventions

BMS-741672DRUG

Tablets, Oral, 100 mg, once daily, 3 weeks

PlaceboDRUG

Tablets, Oral, 0 mg, once daily, 3 weeks treatment period, 2 weeks washout, and 2 weeks follow-up

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 or 2 diabetics with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 12 months duration * Screening HbA1c of ≥ 7% and ≤ 10% * BMI ≤ 40 kg/m2 Exclusion Criteria: * Patients with clinically significant, progressive, or potentially unstable disease of any body system including cardiovascular, gastrointestinal, central nervous system (CNS), psychiatric, endocrine (other than diabetes), tuberculosis or renal * Women of childbearing potential

Locations (8)

University Clinical Investigators, Inc.

Tustin, California, United States

Palm Beach Neurological Center

Palm Beach Gardens, Florida, United States

Comprehensive Neurosciences, Inc.

St. Petersburg, Florida, United States

The Pain & Rehabilitation Clinic Of Chicago

Outcomes

Primary Outcomes

Reduction in weekly average pain score for BMS drug vs. placebo, computed from diary scores

Time frame: recorded during the last 7 days of treatment in each period

Secondary Outcomes

Other glycemic, vascular, and mechanism-based biomarkers will be measured

Time frame: throughout the study

Data from ClinicalTrials.gov

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