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
100 participants
INTERVENTIONAL
2011-03-31
2012-06-30
Brief Summary
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Detailed Description
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Interventional model: Cross-over Placebo Controlled
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
Arm description: BMS-954561 40mg or 80mg three times daily (TID) to Placebo OR Placebo to 40mg or 80mg TID.
Arm type: Active to Placebo or Placebo to Active (cross-over)
BMS-954561
Placebo
Arm 2 BMS-954561 150mg or 300mg
Arm description: BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID
Arm type: Active to Placebo or Placebo to Active(cross-over)
BMS-954561
Placebo
Interventions
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BMS-954561
BMS-954561
Placebo
Eligibility Criteria
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Inclusion Criteria
* Based on patient diary information collected during the Baseline week (day -7 to randomization Day 1), patient has completed at least 5 diary entries and has an average weekly pain rating of at least 4 on the 11-point pain rating scale.
* The patient is able to satisfactorily complete, in the Investigator's judgment, the Cognitive Battery.
* Male or female, 18-85 years of age.
Exclusion Criteria
* History of complete lack of response to pregabalin (at least 300 mg qd for 4 weeks) or gabapentin (at least 1800 mg qd for 4 weeks).
* Hemoglobin A1c \> 9%
* Hemoglobin ≤ 9 g/dL.
* Active herpes zoster or known viral infection.
* Previous neurolytic or neurosurgical therapy for PHN.
* Estimated glomerular filtration rate (eGFR) according to the re-expressed abbreviated (four-variable) Modification of Diet in Renal Disease (MDRD) Study equation ≤ 40ml/min/1.73m2.
* Patients who have been on a stable dose of anticonvulsant,anticholinergic, antiviral medications, nicotine replacements, or any other smoking cessation medications 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, antidepressants, or anticonvulsants). Patients are allowed to participate if on a stable dose for at least 4 weeks prior to randomization (Day1) and should remain stable during course of 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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Arizona Research Center
Phoenix, Arizona, United States
Torrance Clinical Research
Lomita, California, United States
Alpine Clinical Research Center
Boulder, Colorado, 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
Drug Studies America
Marietta, Georgia, United States
Commonwealth Biomedical Research, Llc
Madisonville, Kentucky, United States
Analgesic Solutions
Natick, Massachusetts, United States
Quest Research Institute
Farmington Hills, Michigan, United States
The Center For Pharmaceutical Research. Pc
Kansas City, Missouri, United States
Medex Healthcare Research, Inc
St Louis, Missouri, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Wake Research Associates, Llc
Raleigh, North Carolina, United States
Pmg Research Of Winston-Salem
Winston-Salem, North Carolina, United States
Radiant Research, Inc.
Akron, Ohio, United States
Cor Clinical Research
Oklahoma City, Oklahoma, United States
Futuresearch Trials Of Neurology
Austin, Texas, United States
Local Institution
Bordeaux, , France
Local Institution
Boulogne-Billancourt, , France
Local Institution
Nice, , France
Local Institution
Saint-Priest-en-Jarez, , France
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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2010-023041-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CN169-002
Identifier Type: -
Identifier Source: org_study_id