A TWO WEEK DOUBLE-BLIND PLACEBO-CONTROLLED CROSSOVER STUDY TO COMPARE THE EFFICACY AND SAFETY OF A PREGABALIN/PF-00489791 COMBINATION VERSUS PREGABALIN ALONE IN PATIENTS WITH POST-HERPETIC NEURALGIA
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 72
- 试验地点
- 39
- 主要终点
- Mean Pain Score on Daily Pain Rating Scale (DPRS)
研究概览
简要总结
Pregabalin is an alpha-2 delta ligand approved for the treatment of neuropathic pain, however, not all patients will respond to this drug. This study will compare the efficacy of pregabalin when administered with an experimental drug PF-00489791, in patients with post-herpetic neuralgia. The efficacy of this combination will be compared to pregabalin alone.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male or female of non-childbearing potential
- •Pain present for more than 3 months after healing of herpes zoster skin rash
- •VAS score of >=40mm at screening and baseline visits
排除标准
- •Patients with pain conditions which might impair the assessment of postherpetic neuralgia
- •Skin conditions in the affected dermatome that could alter sensation other than postherpetic neuralgia
- •History or diagnosis of DSM IV major depressive disorder
研究组 & 干预措施
1
干预措施: pregabalin (Drug)
2
干预措施: pregabalin/PF-00489791 (Drug)
3
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Pain Score on Daily Pain Rating Scale (DPRS)
时间窗: End of treatment period (included both Week 2 and Week 6)
Pain was assessed by using a daily pain rating scale that consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"), higher scores indicate more pain intensity. Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily. The mean pain score was defined as the mean of the last 7 daily pain ratings scale scores while taking study medication, at end of each treatment period: Period 1 (Week 2) and Period 2 (Week 6), respectively. Mean pain score had a score range of 0 (no pain) to 10 (worst possible pain), higher scores indicate more pain. Cumulative data of mean pain scores at end of treatment for both the periods was calculated and reported in terms of adjusted mean and standard error.
次要结局
- Neuropathic Pain Symptom Inventory (NPSI)(End of treatment period (included both Week 2 and Week 6))
- Number of Participants With Clinically Significant Vital Signs Abnormalities(Baseline up to Week 7)
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities(Baseline up to Week 7)
- Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology(Baseline up to Week 7)
- Percentage of Participants With Patient Global Impression of Change (PGIC) Score(End of treatment period (included both Week 2 and Week 6))
- Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis(Baseline up to Week 7)
- Pain Visual Analogue Scale (VAS) at Baseline and Week 4(Baseline, Week 4)
- Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry(Baseline up to Week 7)