BMS-741672 for Diabetic Neuropathic Pain - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00683423

Purpose

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

Condition	Intervention	Phase
Neuropathic Pain	Drug: BMS-741672 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Other glycemic, vascular, and mechanism-based biomarkers will be measured [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	July 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: BMS-741672 Tablets, Oral, 100 mg, once daily, 3 weeks
B: Placebo Comparator	Drug: Placebo Tablets, Oral, 0 mg, once daily, 3 weeks treatment period, 2 weeks washout, and 2 weeks follow-up

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683423

Locations

United States, California
University Clinical Investigators, Inc.
Tustin, California, United States, 92780
United States, Florida
Comprehensive Neurosciences, Inc.
St. Petersburg, Florida, United States, 33702
Palm Beach Neurological Center
Palm Beach Gardens, Florida, United States, 33418
United States, Illinois
The Pain & Rehabilitation Clinic Of Chicago
Chicago, Illinois, United States, 60610
United States, Nevada
Advanced Biomedical Research Of America
Las Vegas, Nevada, United States, 89123
United States, North Carolina
Physicians East P.A.
Greenville, North Carolina, United States, 27834
United States, Ohio
Neurology Center Of Ohio
Toledo, Ohio, United States, 43623
United States, Texas
Research Institute Of Dallas, P.A.
Dallas, Texas, United States, 75231

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	MB114-006
Study First Received:	May 21, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00683423
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on January 16, 2009