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临床试验/NCT00141219
NCT00141219已完成3 期

A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pregabalin (150 mg - 600 mg/Day) Using a Flexible, Optimized Dose Schedule in Subjects With Peripheral Neuropathic Pain

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 241 人开始时间: 2005年12月最近更新:
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适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
241
试验地点
1
主要终点
Daily Pain Rating Scale (DPRS)- Mean Pain Score (ITT Population)
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

To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Diagnosis of peripheral neuropathic pain syndrome, including diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), or post-traumatic neuropathic pain (including post-surgical), confirmed by a qualified pain specialist.
  • •Subjects must have completed at least 4 daily pain diaries during the 7 days prior to Visit 2 and have an average pain score of ≥4 over the 7 days prior to Visit 2 (randomization).

排除标准

  • •Neurologic disorders unrelated to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical), that may confuse or confound the assessment of neuropathic pain.
  • •Presence of any severe pain associated with conditions other than DPN, PHN, or post-traumatic neuropathic pain (including post-surgical) that may confound the assessment or self evaluation of the pain due to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical).
  • •Creatinine clearance < 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation in Appendix E). Maximum dose for subjects with creatinine clearance of 30 to 60 mL/min is 300 mg/day

研究组 & 干预措施

1

Experimental

干预措施: pregabalin (Drug)

2

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Daily Pain Rating Scale (DPRS)- Mean Pain Score (ITT Population)

时间窗: Endpoint- Week 8 or Early Discontinuation

DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication.

次要结局

  • Mean Sleep Score as Computed by DSIS.(Weeks 1 to 8)
  • Daily Pain Rating Scale (DPRS)- Number of 30% Responders (With Respect to Pain Scores)(Endpoint- Week 8 or Early Discontinuation)
  • Daily Pain Rating Scale (DPRS)- Number of 50% Responders (With Respect to Pain Scores)(Endpoint- Week 8 or Early Discontination)
  • Daily Pain Rating Scale (DPRS)- Weekly Mean Pain Score(Weeks 1 to 8)
  • Duration Adjusted Average Change (DAAC) of (Adjusted) Mean Pain Score(Weeks 1 to 8)
  • Mean Sleep Interference Score Based on Daily Sleep Interference Scale (DSIS).(Endpoint- Week 8 or Early Discontinuation)
  • Medical Outcome Study (MOS) Optimal Sleep: Number of Participants With Optimal Sleep(Week 8)
  • Medical Outcome Study (MOS) Sleep Adequacy(Week 8)
  • Medical Outcome Study (MOS) Somnolence(Week 8)
  • Medical Outcome Study (MOS) Overall Sleep Problems Index(Week 8)
  • Euro Quality of Life (QOL) (EQ-5D) Utility Score(Week 8)
  • Medical Outcome Study (MOS) Sleep Disturbance(Week 8)
  • Medical Outcome Study (MOS) Snoring Score(Week 8)
  • Medical Outcome Study (MOS) Awaken Short of Breath or Headache(Week 8)
  • Medical Outcome Study (MOS) Sleep Quantity(Week 8)
  • Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS)(Week 8)
  • Hospital Anxiety and Depression Scale- Anxiety (HADS-A) Score(Week 8)
  • Hospital Anxiety and Depression Scale- Depression (HADS-D) Score(Week 8)
  • Patient Global Impression of Change (PGIC)(Week 8)
  • Clinical Global Impression of Change (CGIC)(Week 8)
  • Duration Adjusted Average Change (DAAC) of (Unadjusted) Mean Pain Score(Weeks 1 to 8)

研究者

发起方
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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