BMS-741672 for Diabetic Neuropathic Pain | NCT00683423

Studies
BMS-741672 for Diabetic Neuropathic Pain

NCT00683423

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Oct 12, 2015Estimated

Enrollment

50Actual

Phase

Phase 2

Conditions

Neuropathic Pain

Interventions

BMS-741672
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

May 21, 2008

First Submission Date that Met QC Criteria

May 21, 2008

First Posted Date

May 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Sep 10, 2010

Certification/Extension First Submitted that Passed QC Review

Sep 13, 2010

Certification/Extension First Posted Date

Sep 15, 2010Estimated

Last Update Submitted Date

Sep 23, 2015

Last Update Posted Date

Oct 12, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Drug: BMS-741672
B	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-741672	Drug	Tablets, Oral, 100 mg, once daily, 3 weeks	A
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Other glycemic, vascular, and mechanism-based biomarkers will be measured		throughout the study

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Clinical Investigators, Inc.		Tustin	California	92780	United States
Palm Beach Neurological Center

Condition Browse Module

MeSH Terms

ID	Term
D009437	Neuralgia

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided