A Randomized, Multicenter, Double-blind, Placebo and Active-controlled, Cross-over Study of the Efficacy and Safety of BMS-954561 in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

Bristol-Myers Squibb22 个研究点分布在 2 个国家目标入组 178 人开始时间: 2011年3月最近更新: 2015年12月7日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 178
试验地点: 22
主要终点: The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared to placebo in the treatment of patients with diabetic peripheral neuropathic pain (DPNP).

详细描述

Allocation: Randomized Stratified; Intervention Model: Cross-over Versus Comparator + Placebo

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Type I or Type II diabetes with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 6 months duration.
•Score of ≥3 on Michigan Neuropathy Screening Instrument
•The patient is able to satisfactorily complete, in the Investigator's judgment, the Cognitive Battery.
•Based on patient diary information collected during the Screening/Baseline period, the patient has completed at least 5 of 7 daily diary entries and has an average weekly pain rating of at least 4 on the 11-point pain rating scale, in the week immediately prior to randomization (Baseline Visit).
•Male or female, 18-85 years of age.

排除标准

•History of complete lack of response to Pregabalin (at least 300 mg qd for 4 weeks) or Gabapentin (at least 1800 mg qd for 4 weeks).
•Other severe pain that may potentially confound pain assessment.
•Hemoglobin A1c > 9%
•Hemoglobin ≤ 9 g/dL
•Estimated glomerular filtration rate (eGFR) according to the re-expressed abbreviated (four-variable) Modification of Diet in Renal Disease (MDRD) Study equation ≤ 50ml/min/1.73m2
•Patients who have been on a stable dose of anticonvulsant, anticholinergic, diabetic meds, nicotine replacements, or any other smoking cessation meds for <4 weeks prior to randomization. Patients who are on stable doses for ≥ 4 weeks prior to randomization are allowed, however, there should be no adjustments to the dose of these medications during study.
•Patients currently on more than one drug for treatment of neuropathic pain (low dose opioids or antidepressants). Patients are allowed to participate if on a stable dose of for at least 4 weeks prior to randomization (Day1) and should remain stable during study.