A Randomized, Double-blind, Placebo and Active-controlled, Parallel-group Study to Evaluate the Analgesic Efficacy and Safety of Dexketoprofen Trometamol and Tramadol Hydrochloride Oral Fixed Combination on Moderate to Severe Acute Pain Following Abdominal Hysterectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 606
- 试验地点
- 28
- 主要终点
- SPID8 (Sum of Pain Intensity Differences Over 8 Hours)
研究概览
简要总结
This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison to the single agents (and placebo for the single dose phase only).
Approximately 600 female patients presenting moderate to severe pain after a total/subtotal abdominal hysterectomy are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery.
详细描述
In this clinical trial patients were randomized to the described 6 treatment arms, where each arm define the treatment to be received in the first single dose phase (lasting 8 hours after the 1st treatment intake) and in the subsequent multiple-dose phase (lasting from the second treatment intake up to the 8 hours after the last intake). Namely:
- DKP/TRAM followed by DKP/TRAM;
- DKP followed by DKP;
- TRAM followed by TRAM;
- placebo followed by DKP;
- placebo followed by TRAM;
- placebo followed by DKP/TRAM;
The analyses of endpoints pertinent to the single dose phase were performed combining all the 3 treatment arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.
The analysis of endpoints pertinent to the multiple dose phase were performed combining the treatment arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18 to 75 years.
- •Scheduled to undergo a total or subtotal abdominal hysterectomy (with or without salpingo-oophorectomy) for benign conditions.
- •Patients experiencing pain at rest of at least moderate intensity the day after surgery.
排除标准
- •Patients not suitable for study treatments and rescue medication (RM) or those for whom non-steroidal anti-inflammatory drugs (NSAIDs), opioids, acetyl salicylic acid, pyrazolones or pyrazolidines are contraindicated.
- •Patients with clinically significant abnormalities in vital signs, safety laboratory tests and 12-lead ECG at screening.
- •Patients with history of any illness or condition that might pose a risk to the patient or confound the efficacy and safety study results.
- •Patients using and not suitable to withdraw analgesics other than those specified in the protocol.
- •Patients using and not suitable for withdrawing any of the prohibited medication specified in the protocol.
- •Breastfeeding women.
研究组 & 干预措施
DKP/TRAM followed by DKP/TRAM
Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
干预措施: Dexketoprofen/Tramadol-single dose (Drug)
DKP/TRAM followed by DKP/TRAM
Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
干预措施: Dexketoprofen/Tramadol-multiple doses (Drug)
DKP followed by DKP
Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
干预措施: Dexketoprofen-single dose (Drug)
DKP followed by DKP
Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
干预措施: Dexketoprofen-multiple doses (Drug)
TRAM followed by TRAM
Tramadol-single dose followed by Tramadol-multiple doses
干预措施: Tramadol-single dose (Drug)
TRAM followed by TRAM
Tramadol-single dose followed by Tramadol-multiple doses
干预措施: Tramadol-multiple doses (Drug)
Placebo followed by DKP/TRAM
Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
干预措施: Placebo (Drug)
Placebo followed by DKP/TRAM
Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
干预措施: Dexketoprofen/Tramadol-multiple doses (Drug)
Placebo followed by DKP
Placebo single dose followed by Dexketoprofen-multiple doses
干预措施: Placebo (Drug)
Placebo followed by DKP
Placebo single dose followed by Dexketoprofen-multiple doses
干预措施: Dexketoprofen-multiple doses (Drug)
Placebo followed by TRAM
Placebo single dose followed by Tramadol-multiple doses
干预措施: Placebo (Drug)
Placebo followed by TRAM
Placebo single dose followed by Tramadol-multiple doses
干预措施: Tramadol-multiple doses (Drug)
结局指标
主要结局
SPID8 (Sum of Pain Intensity Differences Over 8 Hours)
时间窗: over 8 hours after the first dose
Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief. The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.
次要结局
- Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)(over 8 hours after first dose)
- SPID48 (Sum of Pain Intensity Differences Over 48 Hours of the Multiple-dose Phase)(over 48 hours of the multiple-dose phase)
- Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale)(over 48 hours of the multiple-dose phase)