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Completed

NCT Number: NCT00683423

BMS-741672 for Diabetic Neuropathic Pain

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

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Clinical Investigators, Inc., Tustin, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-741672

Drug

Tablets, Oral, 100 mg, once daily, 3 weeks

Placebo

Drug

Tablets, Oral, 0 mg, once daily, 3 weeks treatment period, 2 weeks washout, and 2 weeks follow-up

Primary outcomes

  1. 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 outcomes

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

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 23, 2008
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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