Randomized, Double-Blind, Active-and Placebo-Controlled Study of the Analgesic Efficacy and Safety of Repeated Dosing of DIC075V Versus Parenteral Ketorolac and Placebo in Acute Post-Operative Pain After Elective Orthopedic Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 277
- 试验地点
- 8
- 主要终点
- Sum of the Pain Intensity Differences (SPID) Over 72 Hours
研究概览
简要总结
This study will compare repeated intermittent IV dosing of diclofenac in patient with moderate to severe post-surgical pain from elective orthopedic surgery.
详细描述
The primary objective is to evaluate the analgesic efficacy and safety of three dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac tromethamine.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled within three weeks of the screening visit to undergo elective orthopedic surgery.
- •Moderate to severe pain within 6 hours following completion of the required surgery.
排除标准
- •Chronic pain conditions.
- •Chronic disease or recent cardiovascular events.
- •Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.
研究组 & 干预措施
A
DIC075V (IV diclofenac)
干预措施: IV Diclofenac (Drug)
B
IV Ketorolac
干预措施: IV ketorolac (Drug)
C
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Sum of the Pain Intensity Differences (SPID) Over 72 Hours
时间窗: Over 72 hours post first dose
Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 72 hours ranges from -7200 to 7200. A higher value indicates a better pain reduction.
Sum of the Pain Intensity Differences (SPID) Over 96 Hours
时间窗: Over 96 hours post first dose
Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 96 hours ranges from -9600 to 9600. A higher value indicates a better pain reduction.
Sum of the Pain Intensity Differences (SPID) Over 24 Hours
时间窗: Over 24 hours post first dose
Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 24 hours ranges from -2400 to 2400. A higher value indicates a better pain reduction.
Sum of the Pain Intensity Differences (SPID) Over 48 Hours
时间窗: Over 48 hours post first dose
Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 48 hours ranges from -4800 to 4800. A higher value indicates a better pain reduction.
Sum of the Pain Intensity Differences (SPID) Over 120 Hours
时间窗: Over 120 hours post first dose
Pain intensity was measured on VAS (from 0 mm to 100 mm: 0 = no pain, 100 = worst possible pain). For each post dose time point, PID is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. SPIDs was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 120 hours ranges from -12000 to 12000. A higher value indicates a better pain reduction.
次要结局
- Percentage of Participants Attaining Greater Than or Equal to (>=) 30 Percent (%) Reduction From Baseline in Pain Intensity(Baseline (0 hour), 5, 30 minutes post first dose, 1, 24, 48, 72, 90, 120 hours post first dose)
- Total Pain Relief (TOTPAR)(0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose)
- Participant Global Evaluation Over Time(0-24, 0-48, 0-120 hours post-dose)
- Pain Intensity Differences (PID) Over Time(Baseline (0 hour), 5, 10, 15, 30, 45 minutes post first dose, 1, 2, 3, 5, 6, 9, 12, 15, 18, 21, 24, 48, 72, 96, 120 hours post first dose)
- Visual Analog Pain Relief Values Over the Time(5, 10, 15, 30, 45 minutes post first dose, 1, 2, 3, 5, 6, 9, 12, 15, 18, 21, 24, 48, 72, 96, 120 hours post first dose)
- Time From Administration of Study Drug to Administration of Rescue Medication(Maximum up to 5 days)
- Number of Participants According to Frequency of Use of Rescue Medication(0-24, 0-48, 0-72, 0-96 and 0-120 hours post first dose)
- Cumulative Amount of Rescue Medication(0-24, 0-48, 0-72, 0-96 and 0-120 hours)
- Time to Perceptible Relief(Within 6 hours of first dose on Day 1)
- Time to Meaningful Relief(Within 6 hours of first dose on Day 1)