BMS-741672 for Diabetic Neuropathic Pain

Phase 2

Completed

• Conditions: Neuropathic Pain
• Interventions: Drug: BMS-741672; Drug: Placebo

• Registration Number: NCT00683423
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-21
• Study First Posted: 2008-05-23
• Study Start: 2008-07
• Primary Completion: 2009-01
• Study Completion: 2009-02
• Disposition First Submitted: 2010-09-10
• Disposition First Submitted QC: 2010-09-13
• Disposition First Posted: 2010-09-15
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-23
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	BMS-741672	-
B	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Other glycemic, vascular, and mechanism-based biomarkers will be measured	throughout the study

Trial Locations

Locations (8)

University Clinical Investigators, Inc.; 🇺🇸 Tustin, California, United States

Palm Beach Neurological Center; 🇺🇸 Palm Beach Gardens, Florida, United States

Research Institute Of Dallas, P.A.; 🇺🇸 Dallas, Texas, United States

Advanced Biomedical Research Of America; 🇺🇸 Las Vegas, Nevada, United States

Neurology Center Of Ohio; 🇺🇸 Toledo, Ohio, United States

Comprehensive Neurosciences, Inc.; 🇺🇸 St. Petersburg, Florida, United States

The Pain & Rehabilitation Clinic Of Chicago; 🇺🇸 Chicago, Illinois, United States

Physicians East P.A.; 🇺🇸 Greenville, North Carolina, United States