BMS-741672 for Diabetic Neuropathic Pain
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial to Evaluate the Efficacy and Safety of BMS-741672 in Patients With Diabetic Neuropathic Pain
1 other identifier
interventional
50
1 country
8
Brief Summary
The purpose of the study is to determine whether BMS-741672 improves neuropathic pain in diabetic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2008
Shorter than P25 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2008
CompletedFirst Posted
Study publicly available on registry
May 23, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedOctober 12, 2015
September 1, 2015
6 months
May 21, 2008
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Other glycemic, vascular, and mechanism-based biomarkers will be measured
throughout the study
Study Arms (2)
A
EXPERIMENTALB
PLACEBO COMPARATORInterventions
Tablets, Oral, 0 mg, once daily, 3 weeks treatment period, 2 weeks washout, and 2 weeks follow-up
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
Palm Beach Neurological Center
Palm Beach Gardens, Florida, 33418, United States
Comprehensive Neurosciences, Inc.
St. Petersburg, Florida, 33702, United States
The Pain & Rehabilitation Clinic Of Chicago
Chicago, Illinois, 60610, United States
Advanced Biomedical Research Of America
Las Vegas, Nevada, 89123, United States
Physicians East P.A.
Greenville, North Carolina, 27834, United States
Neurology Center Of Ohio
Toledo, Ohio, 43623, United States
Research Institute Of Dallas, P.A.
Dallas, Texas, 75231, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 21, 2008
First Posted
May 23, 2008
Study Start
July 1, 2008
Primary Completion
January 1, 2009
Study Completion
February 1, 2009
Last Updated
October 12, 2015
Record last verified: 2015-09