NCT00683423CompletedPhase 2
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial to Evaluate the Efficacy and Safety of BMS-741672 in Patients With Diabetic Neuropathic Pain
Bristol-Myers Squibb8 sites in 1 country50 target enrollmentStarted: July 2008Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 8
- Primary Endpoint
- Reduction in weekly average pain score for BMS drug vs. placebo, computed from diary scores
Study Overview
Brief Summary
The purpose of the study is to determine whether BMS-741672 improves neuropathic pain in diabetic patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
B
Placebo Comparator
Intervention: Placebo (Drug)
A
Experimental
Intervention: BMS-741672 (Drug)
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(throughout the study)
Investigators
Study Sites (8)
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