Neuropathic Pain
Conditions
Brief summary
The purpose of the study is to determine whether BMS-741672 improves neuropathic pain in diabetic patients.
Interventions
DRUGBMS-741672
Tablets, Oral, 100 mg, once daily, 3 weeks
DRUGPlacebo
Tablets, Oral, 0 mg, once daily, 3 weeks treatment period, 2 weeks washout, and 2 weeks follow-up
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Other glycemic, vascular, and mechanism-based biomarkers will be measured | throughout the study |
Countries
United States
Outcome results
None listed