Analgesic Efficacy of Oral Dexketoprofen Trometamol/Tramadol Hydrochloride Versus Tramadol Hydrochloride/Paracetamol: a Randomised, Double-blind, Placebo and Active-controlled, Parallel Group Study in Moderate to Severe Acute Pain After Removal of Impacted Lower Third Molar (Dexketoprofen Analgesic eVolution wIth tramaDol- DAVID Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 654
- 试验地点
- 18
- 主要终点
- TOTPAR6 (Total Pain Relief Over 6 Hours Post-dose)
研究概览
简要总结
The study is aimed to evaluate the analgesic efficacy of TRAM.HCl/DKP.TRIS 75mg/25mg oral fixed drug combination in comparison with TRAM.HCl /paracetamol 75mg/650mg in the treatment of moderate to severe acute pain.
详细描述
The present phase IV study is a randomised, double-blind, placebo and active-controlled, parallel group study in moderate to severe acute pain after removal of impacted lower third molar.
In this single-dose clinical trial patients are randomized to the following 3 treatment arms in a 2:2:1 ratio:
- TRAM.HCL/DKP.TRIS
- Paracetamol/TRAM.HCL
- Placebo.
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
- •Male or female patients aged more than 18 years. Females participating in the study must be either non-childbearing potential or routinely using an effective method of birth control resulting in a low failure rate.
- •Scheduled for outpatient surgical extraction -under local anaesthesia of lower third molar teeth, with at least one partially impacted in the mandible requiring bone manipulation.
- •Pain of at least moderate intensity in the first 4 hours after the end of surgery (NRS score ≥ 4).
排除标准
- •History of allergy or hypersensitivity to the study treatments, RM or to any other NSAIDs, opioids and acetyl salicylic acid.
- •History of peptic ulcer, gastrointestinal disorders by NSAIDs or gastrointestinal bleeding or other active bleedings.
- •History of any illness or condition that, in the opinion of the Investigator might pose a risk to the patient or confound the efficacy and safety results of the study.
- •Patients using and not suitable for withdrawing the prohibited medications specified in the protocol.
研究组 & 干预措施
Tramadol/Dexketoprofen
Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose;
Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x [37.5mg/325mg] film-coated tablets, oral single dose.
干预措施: Tramadol Hydrochloride/Dexketoprofen Trometamol (Drug)
Tramadol/Dexketoprofen
Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose;
Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x [37.5mg/325mg] film-coated tablets, oral single dose.
干预措施: Placebo (Drug)
Tramadol/Paracetamol
Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x [37.5mg/325mg] film-coated tablets, oral single dose;
Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose.
.
干预措施: Tramadol Hydrochloride/Paracetamol (Drug)
Tramadol/Paracetamol
Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x [37.5mg/325mg] film-coated tablets, oral single dose;
Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose.
.
干预措施: Placebo (Drug)
Placebo
Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose;
Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose.
干预措施: Placebo (Drug)
结局指标
主要结局
TOTPAR6 (Total Pain Relief Over 6 Hours Post-dose)
时间窗: 6 hours post-dose
TOTPAR calculated as the weighted sum of the PAR scores, measured according to a 5-point VRS (Verbal Rating Scale) from 0=no relief to 4=complete relief, over 6 hours post-dose (TOTPAR6). The TOTPAR6 ranges from a minimum of 0 to a maximum of 24.
次要结局
- % of Patients Requiring RM (Rescue Medication)(8 hours post-dose)
- % of Patients Achieving 50% of Max TOTPAR(8 hours post-dose)
- % of Patients Achieving at Least 30% of PI (Pain Intensity) Reduction Over 8 Hours Post-dose(8 hours post-dose)
- Time to Confirmed FPPAR (First Perceptible Pain Relief)(2 hours post-dose)
- PGE (Patient Global Evaluation)(8 hours postdose)