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BMS-741672 for Diabetic Neuropathic Pain

Primary Purpose

Neuropathic Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BMS-741672
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Clinical Investigators, Inc.
  • Palm Beach Neurological Center
  • Comprehensive Neurosciences, Inc.
  • The Pain & Rehabilitation Clinic Of Chicago
  • Advanced Biomedical Research Of America
  • Physicians East P.A.
  • Neurology Center Of Ohio
  • Research Institute Of Dallas, P.A.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Reduction in weekly average pain score for BMS drug vs. placebo, computed from diary scores

Secondary Outcome Measures

Other glycemic, vascular, and mechanism-based biomarkers will be measured

Full Information

First Posted
May 21, 2008
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00683423
Brief Title
BMS-741672 for Diabetic Neuropathic Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-741672
Intervention Description
Tablets, Oral, 100 mg, once daily, 3 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, 0 mg, once daily, 3 weeks treatment period, 2 weeks washout, and 2 weeks follow-up
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Other glycemic, vascular, and mechanism-based biomarkers will be measured
Time Frame
throughout the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University Clinical Investigators, Inc.
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Palm Beach Neurological Center
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33418
Country
United States
Facility Name
Comprehensive Neurosciences, Inc.
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33702
Country
United States
Facility Name
The Pain & Rehabilitation Clinic Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Advanced Biomedical Research Of America
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Physicians East P.A.
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Neurology Center Of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Research Institute Of Dallas, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

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BMS-741672 for Diabetic Neuropathic Pain

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