2023-505687-11-00招募中3 期
Phase III, double-blind, randomised, placebo- and active treatment-controlled clinical trial to evaluate the analgesic efficacy and safety of a combination of ibuprofen (arginate)-tramadol hydrochloride 400-37.5 mg, administered intravenously to patients with acute severe postoperative pain.
Farmalider S.A.10 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2023年9月12日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 216
- 试验地点
- 10
- 主要终点
- Sum of Pain Intensity Differences from the start of administration to 4 hours (SPID0-4h) , measured using the Numeric Rating Scale for Pain at baseline, 1 h, 2 h, 3 h and 4 h.
研究概览
简要总结
To assess whether the fixed-dose combination of ibuprofen (arginate)-tramadol hydrochloride 400-37.5 mg IV/4 hours, administered post-operatively to patients with severe pain, achieves non-inferior pain control at 4 h as compared to the administration of 100 mg of tramadol alone and better pain control than placebo.
研究设计
- 分配方式
- Randomized
- 主要目的
- Fmld-febetradi-53 Fiii
- 盲法
- Double (Subject, Analyst, Investigator, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients who grant written informed consent (IC) and who are able to comply with the scheduled study procedures. Informed consents obtained verbally during the telephone consultation, documented in the medical record and signed by patients at the next visit to the study site will be accepted.
- •Patients aged ≥ 18 years at the screening visit.
- •Patients with body mass index ≥ 18.5 and < 40 kg/m2 at the screening visit.
- •Patients scheduled for open or laparoscopic surgery for myomectomy, total or partial hysterectomy due to benign conditions, oophorectomy, salpingo-oophorectomy, cholecystectomy, haemorrhoidectomy or tonsillectomy.
- •Patients with an American Society of Anesthesiologists (ASA) anaesthesia risk score of I or II.
- •After surgery and prior to randomisation: Patients with a Numeric Rating Scale (NRS) for pain score of ≥ 6 after surgery.
排除标准
- •Patients with a history of allergy or hypersensitivity to the study medication, rescue medication or any of the excipients.
- •Serious unresolved infection on the day of surgery.
- •Any other disease, relevant laboratory test alteration or condition which in the investigator’s opinion could interfere with the results of the study or constitute a risk for the subject if he/she participates in the study.
- •Patients currently enrolled in or who have participated in a clinical trial with medicinal products or devices in the 30 days prior to the screening visit.
- •Women who are pregnant or breastfeeding.
- •History of bronchospasm, asthma, rhinitis, angioedema or urticaria associated with the use of aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
- •Active or recurrent peptic ulcer and/or gastrointestinal bleeding, or a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs.
- •Bleeding diathesis or coagulation disorders.
- •Patients with moderate or severe renal, liver or heart failure (New York Heart Association [NYHA] class III-IV).
- •Patients with uncontrolled epilepsy.
- •History of dependence on drugs of abuse: alcohol, opiates, hypnotics, amphetamines, cocaine, hallucinogens, cannabis or synthetic drugs of abuse.
- •Patients under treatment with any medicinal product that should not be administered due to the risk of adverse interactions with the study drug or interference with the study assessments (indicated in section 9.1.
- •of the protocol “Prohibited Medication”).
- •A surgical procedure during the study other than that initially planned or lasting more than 4 hours, and which in the investigator’s opinion could have an impact on the degree or type of post-operative pain and the analgesic response, thereby interfering with the interpretation of the study results.
结局指标
主要结局
Sum of Pain Intensity Differences from the start of administration to 4 hours (SPID0-4h) , measured using the Numeric Rating Scale for Pain at baseline, 1 h, 2 h, 3 h and 4 h.
Sum of Pain Intensity Differences from the start of administration to 4 hours (SPID0-4h) , measured using the Numeric Rating Scale for Pain at baseline, 1 h, 2 h, 3 h and 4 h.
次要结局
- Efficacy assessment: - Sum of Pain Intensity Differences from the start of administration to 8 hours (SPID0-8h), measured using the Numeric Pain Scale at baseline, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h and 8 h.
- Time to first pain relief (↓33% pain), from the scheduled assessment intervals.
- Responder rate, defined as the percentage of patients with an SPID(0-4h) ≥δs.
- Pain intensity measured using the Numeric Pain Scale at baseline, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h and 8 h after the start of treatment.
- Pain intensity difference (PID) at 4 and 8 hours from the start of administration of the study medication.
- Percentage of patients using rescue medication.
- Time to first administration of rescue medication from the start of administration of the study medication.
- Total rescue medication use from start of treatment to 8 hours (measured in number of rescue doses required).
- Safety assessment: Vital signs (body temperature, heart rate, blood pressure and oxygen saturation).
- Safety assessment: Adverse events.
研究者
Carlos Calandria
Scientific
Farmalider S.A.
研究点 (10)
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