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BMS-741672 for Diabetic Neuropathic Pain

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00683423
First received: May 21, 2008
Last updated: January 24, 2011
Last verified: July 2009
  Purpose

The purpose of the study is to determine whether BMS-741672 improves neuropathic pain in diabetic patients.


Condition Intervention Phase
Neuropathic Pain
Drug: BMS-741672
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial to Evaluate the Efficacy and Safety of BMS-741672 in Patients With Diabetic Neuropathic Pain

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other glycemic, vascular, and mechanism-based biomarkers will be measured [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: July 2008
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: BMS-741672
Tablets, Oral, 100 mg, once daily, 3 weeks
Placebo Comparator: B Drug: Placebo
Tablets, Oral, 0 mg, once daily, 3 weeks treatment period, 2 weeks washout, and 2 weeks follow-up

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683423

Locations
United States, California
University Clinical Investigators, Inc.
Tustin, California, United States, 92780
United States, Florida
Palm Beach Neurological Center
Palm Beach Gardens, Florida, United States, 33418
Comprehensive Neurosciences, Inc.
St. Petersburg, Florida, United States, 33702
United States, Illinois
The Pain & Rehabilitation Clinic Of Chicago
Chicago, Illinois, United States, 60610
United States, Nevada
Advanced Biomedical Research Of America
Las Vegas, Nevada, United States, 89123
United States, North Carolina
Physicians East P.A.
Greenville, North Carolina, United States, 27834
United States, Ohio
Neurology Center Of Ohio
Toledo, Ohio, United States, 43623
United States, Texas
Research Institute Of Dallas, P.A.
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00683423     History of Changes
Other Study ID Numbers: MB114-006
Study First Received: May 21, 2008
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neuralgia
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014