BMS-741672 for Diabetic Neuropathic Pain

Neuropathic Pain Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial to Evaluate the Efficacy and Safety of BMS-741672 in Patients With Diabetic Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683423
• Other study ID #: MB114-006
• Status: Completed
• Phase: Phase 2
• First received: May 21, 2008
• Last updated: September 23, 2015
• Start date: July 2008
• Est. completion date: February 2009

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• BMS-741672
Tablets, Oral, 100 mg, once daily, 3 weeks
• Placebo
Tablets, Oral, 0 mg, once daily, 3 weeks treatment period, 2 weeks washout, and 2 weeks follow-up

Locations

Country	Name	City	State
United States	The Pain & Rehabilitation Clinic Of Chicago	Chicago	Illinois
United States	Research Institute Of Dallas, P.A.	Dallas	Texas
United States	Physicians East P.A.	Greenville	North Carolina
United States	Advanced Biomedical Research Of America	Las Vegas	Nevada
United States	Palm Beach Neurological Center	Palm Beach Gardens	Florida
United States	Comprehensive Neurosciences, Inc.	St. Petersburg	Florida
United States	Neurology Center Of Ohio	Toledo	Ohio
United States	University Clinical Investigators, Inc.	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in weekly average pain score for BMS drug vs. placebo, computed from diary scores		recorded during the last 7 days of treatment in each period	No
Secondary	Other glycemic, vascular, and mechanism-based biomarkers will be measured		throughout the study	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form