A Randomised, Double-Blind, Double-Dummy, Placebo And Active Controlled, 4-Way Crossover Methodology Study To Assess The Effect Of Gabapentin, Diphenhydramine And Morphine On Cold Pain In Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Interpolated Average Pain (0-8 Hours)
研究概览
简要总结
Human experimental pain models are useful in understanding the mechanisms underlying clinical pain conditions and can be used to test the analgesic efficacy of drugs used in the management of pain. Once established these models can be used as mechanism biomarkers in early development clinical studies to establish proof of mechanism for novel compounds. The cold pain model is a mechanistic pain biomarker with potential application in proof of mechanism studies. In this study we aim to set up this cold pain model at a Clinical Research Unit and demonstrate we can effectively screen subjects for this model and examine the effect of morphine, diphenhydramine, and gabapentin in the cold pain model.
详细描述
Cold pain methodology development
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers having given consent to participate in the study who have no clinically significant anomalies and whose vital signs are within normal range.
- •Subject having performed the cold pain test reproducibly ie, if the area under the pain-time curve (AUC) must be within 20% during successive tests within one cold pain test screening visit and within 30% between the two cold pain test screening visits.
排除标准
- •Subject who have had a serious adverse reaction or significant hypersensitivity to any of the study drugs.
- •Subjects with a history of or evidence of any neurological condition which could affect pain sensation.
- •Subjects with an AUCcpt 0-120 sec in the cold pain test of <1000 in any of the screening tests (excluding familiarization).
研究组 & 干预措施
Gabapentin 1200mg
干预措施: Gabapentin (Drug)
Diphenhydramine 50 mg
干预措施: Diphenhydramine (Drug)
Morphine 10 mg
干预措施: Morphine (Drug)
Placebo formulations
干预措施: Placebo (Drug)
结局指标
主要结局
Interpolated Average Pain (0-8 Hours)
时间窗: Pre-dose to 8 hours post-dose
Interpolated average pain (0 to 8 hours): area under the curve (AUC) of average pain (0 to 120 seconds) recorded at each of the time points taken over 8 hour time period divided by 8.
Average Pain (0-120 Seconds): Cold Pain Test Visual Analog Scale (VAS)
时间窗: Pre-dose, 1, 1.5, 2, 4, and 8 hours post-dose
Area under the cold pain test Visual Analog Scale (VAS) time curve (AUCcpt 0 to 120 seconds \[sec\]) averaged over the 120 sec for each time point assessed. Participant adjusted 100 millimeter (mm) electronic VAS with range of "no pain" (0) to "maximum pain" (100) at the anchor endpoints of the scale and "moderate pain" at the midpoint. Pain reported while non-dominant hand was placed in thermostatically controlled water bath at 2±1°C for a maximum of 120 sec.
次要结局
- Number of Participants With Clinically Significant Abnormal Findings on Physical Examination(Pre-dose and follow-up visit (at least 7 days after last dosing))
- Number of Participants With Abnormal Pulse Oxymetry Results(Predose through duration of IV infusion dosing)
- Number of Participants With Clinically Significant Findings in Vital Signs(Predose, Day 1, Day 2 each treatment period, follow-up visit (at least 7 days after last dosing))
- Number of Participants With Abnormal Cardiac Monitoring Results(Pre-dose through duration of IV infusion dosing)
- Number of Participants With Abnormal Findings on Electrocardiogram (ECG)(Pre-dose and follow-up visit (at least 7 days after last dosing))
- Number of Participants With Abnormal Haematology, Clinical Chemistry, Urinalysis Results(Pre-dose, follow-up visit (at least 7 days after last dosing))