EUCTR2014-004081-21-HU进行中（未招募）不适用
A PHASE III, MULTICENTRE, INTERNATIONAL, RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY,PARALLEL-GROUP, PLACEBO AND ACTIVE COMPARATORCONTROLLED CLINICAL TRIAL TO EVALUATE THE ANALGESIC EFFICACY AND SAFETY OF IBUPROFEN ARGININE/TRAMADOL 400/37.5 MG COMPARED WITH IBUPROFEN ARGININE 400 MG ALONE, TRAMADOL 50 MG ALONE AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE PAIN AFTER NON-ONCOLOGICAL ABDOMINALHYSTERECTOMY - IOTRA
aboratorios Farmalíder S.A.0 个研究点目标入组 444 人开始时间: 2015年1月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 444
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Main inclusion criteria:
- •1.Female, from 18 to 75 years of age.
- •2.Scheduled for total or partial abdominal hysterectomy due to a benign process, requiring hospitalisation for at least 48 hours after the surgery.
- •3.Mentally competent, able to understand and grant their written informed consent before entering the study. Willing to undergo the scheduled study procedures, including entering their pain assessment value in the patient diary as established in the protocol.
- •4.Class I, II or III of the ASA (American Society of Anesthesiologists) patient classification system.
- •5.Patient with at least moderate (VAS = 4 cm) pain at rest the day after surgery, able to swallow oral medication, for whom randomisation and dose allocation is possible within 4 hours of withdrawing intravenous analgesia.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 144
排除标准
- •1.Patient considered by the investigator to be unsuitable for the study treatment and/or rescue medication (RM) based on her medical history, physical examination, concomitant medication (CM) and concomitant systemic diseases.
- •2.Complications during the surgery or the period prior to randomisation, in the investigator's opinion.
- •3.Local or systemic acute infection at the time of surgery that could confuse the post-surgical assessment.
- •4.Patients with clinical signs of gastritis, history of peptic ulcer, GI haemorrhage or diseases that, in the investigator's opinion, could be negatively affected by the administration of an NSAID.
- •5.Clinical signs or history of clotting disorders that could be negatively affected by the administration of an NSAID.
- •6.Severe liver, kidney or heart failure.
- •7.History of seizures or drug or alcohol abuse in the six months before the study.
- •8.Patients in chronic treatment with NSAIDs and/or opioids (major and tramadol).
- •9.Patients who use and cannot suspend topical or systemic analgesics other than those specified in the protocol, from before the start of the surgery (5 days before in the case of COX-2 inhibitors) until the end of the last pain assessment.
- •10.Patients on treatment with drugs that reduce the seizure threshold (MAO inhibitors, SSRIs, methylphenidate, etc.).
- •11.Hypersensitivity or allergy to the study drugs or RM.
- •12.Patients taking any concomitant medication, the use of which could be susceptible to interacting with ibuprofen and/or tramadol, or could affect safety.
- •13.Breastfeeding women.
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