Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
178 participants
INTERVENTIONAL
2011-03-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Arm 1: BMS-954561 40mg or 80mg
BMS-954561 40mg or 80mg TID to Placebo OR Placebo to 40mg or 80mg TID
Active to Placebo or Placebo to Active (cross-over)
BMS-954561
Placebo matching BMS-954561
Arm 2: BMS-954561 150mg or 300mg
BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID
Active to Placebo or Placebo to Active (cross-over)
BMS-954561
Placebo matching BMS-954561
Arm 3: Pregabalin 100mg
Pregabalin 100mg TID to Placebo OR Placebo to 100mg TID
Active to Placebo or Placebo to Active (cross-over)
Pregabalin
Placebo matching Pregabalin
Interventions
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BMS-954561
Pregabalin
Placebo matching BMS-954561
Placebo matching Pregabalin
Eligibility Criteria
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Inclusion Criteria
* Score of ≥3 on Michigan Neuropathy Screening Instrument
* The patient is able to satisfactorily complete, in the Investigator's judgment, the Cognitive Battery.
* Based on patient diary information collected during the Screening/Baseline period, the patient has completed at least 5 of 7 daily diary entries and has an average weekly pain rating of at least 4 on the 11-point pain rating scale, in the week immediately prior to randomization (Baseline Visit).
* Male or female, 18-85 years of age.
Exclusion Criteria
* Other severe pain that may potentially confound pain assessment.
* Hemoglobin A1c \> 9%
* Hemoglobin ≤ 9 g/dL
* Estimated glomerular filtration rate (eGFR) according to the re-expressed abbreviated (four-variable) Modification of Diet in Renal Disease (MDRD) Study equation ≤ 50ml/min/1.73m2
* Patients who have been on a stable dose of anticonvulsant, anticholinergic, diabetic meds, nicotine replacements, or any other smoking cessation meds for \<4 weeks prior to randomization. Patients who are on stable doses for ≥ 4 weeks prior to randomization are allowed, however, there should be no adjustments to the dose of these medications during study.
* Patients currently on more than one drug for treatment of neuropathic pain (low dose opioids or antidepressants). Patients are allowed to participate if on a stable dose of for at least 4 weeks prior to randomization (Day1) and should remain stable during study.
18 Years
85 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Achieve Clinical Research, Llc
Birmingham, Alabama, United States
Arizona Research Center
Phoenix, Arizona, United States
Torrance Clinical Research
Lomita, California, United States
Office Of Richard S. Cherlin, Md
Los Gatos, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Brain Matters Research
Delray Beach, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Compass Research, Llc
Orlando, Florida, United States
Comprehensive Clinical Development, Inc.
St. Petersburg, Florida, United States
Northwest Neurology Ltd.
Lake Barrington, Illinois, United States
Commonwealth Biomedical Research, Llc
Madisonville, Kentucky, United States
The Center For Pharmaceutical Research. Pc
Kansas City, Missouri, United States
Mercy Health Research
St Louis, Missouri, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Physicians East P.A.
Greenville, North Carolina, United States
Pmg Research Of Winston-Salem
Winston-Salem, North Carolina, United States
Radiant Research, Inc.
Akron, Ohio, United States
Neurology & Neuroscience Center Of Ohio
Toledo, Ohio, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States
Local Institution
Dijon, , France
Local Institution
Nantes, , France
Local Institution
Nice, , France
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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2010-023042-70
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CN169-001
Identifier Type: -
Identifier Source: org_study_id