BMS-741672 for Diabetic Neuropathic Pain

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Neuropathic Pain

Treatments: Drug: Placebo; Drug: BMS-741672

Study type: Interventional

Funder types: Industry

Identifiers

NCT00683423

MB114-006

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: BMS-741672

B

Placebo Comparator group

Treatment:

Drug: Placebo