EUCTR2015-002446-31-ES进行中（未招募）1 期
Phase III clinical trial , multicenter , randomized , double-blind , crossover, active-controlled and placebo to evaluate the analgesic efficacy and safety of paracetamol / ibuprofen 500/200 mg compared with 500 mg paracetamol alone, ibuprofen 200 mg alone and placebo patients with primary dysmenorrhea
ABORATORIOS FARMALIDER S.A.0 个研究点开始时间: 2015年7月10日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •1) Able to understand and sign the informed consent before participating in the study and willing to comply with all procedures and scheduled visits and to collect the information required by the protocol.
- •2) Women aged ? 18 years .
- •3) Primary dysmenorrhea with moderate to severe pain reaching a highest score of 40 mm Visual Analog Scale (VAS > 40 mm )
- •4) At least 4 painful menstrual cycles in the past six months , which have required pain medication .
- •5 ) regular menstrual cycles (28 ± 7 days).
- •6) Good general condition ( in the investigator's opinion), no clinically significant changes in clinical history, physical examination or laboratory tests .
- •7) Commit to use , in the investigator , a reliable method of contraception mind and be willing to continue that birth control throughout the study .
- •8) You agree not to take painkillers except for the protocol defined as rescue medication during the treatment period , until past 72 hours after administration of the first dose of study medication in each of the four study periods .
- •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 184
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) History of allergy or hypersensitivity to the study medication, rescue medication or other nonsteroidal antiinflammatory drugs (NSAIDs), paracetamol or aspirin, or any of its excipients.
- •2) History of asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria or angioneurotic edema.
- •3) a history of peptic ulcer, gastrointestinal disorders NSAIDs, gastrointestinal bleeding or other active bleeding.
- •4) renal failure, liver or moderate to severe heart.
- •5) bleeding diathesis and other coagulation disorders.
- •6) uncontrolled epilepsy.
- •7) Crohn's disease or ulcerative colitis.
- •8) medical history of infection with Human Immunodeficiency Virus (HIV) or any serious immunocompromised state.
- •9) History of any type of malignancy during the five years prior to entry into this study.
- •10) history of drug dependence or alcohol abuse. For the purposes of the study, alcohol dependence is defined as follows: average weekly consumption> 21 units (men) and> 14 units (women), or average daily consumption> 3 units (men) and> 2 units (women ) (One unit corresponds to approx. 125 ml of wine, 200 ml of beer, 25 ml of spirits).
- •11) patients unable to abstain from alcohol, psychotropic drugs or sedatives (eg benzodiazepines) or other banned drugs as related below for 48 hours or 5 half-lives (whichever is longer) before the start of surgery and for 24 hours after administration of study medication. The prohibited drugs are: different analgesics study medication, anticoagulants, thrombolytics and antiplatelet agents, corticosteroids, MAO inhibitors, anticonvulsants, antipsychotics, inhibitors of serotonin reuptake and tricyclic antidepressants, lithium, methotrexate, sulfonamides.
- •12) Patients who have received an analgesic, anti-inflammatory, antispasmodic or other treatment for dysmenorrhea within 6 hours before taking the study medication
- •13) who received an experimental drug or used an experimental medical device within 30 days prior to screening.
- •14) pregnant or lactating women.
- •15) History of any disease or condition that, at the discretion of the investigator, would constitute a risk to the patient or alter the results of the study (eg patients with acute pain from any other source or location).
- •16) They may not meet the requirements of the study or in the investigator's opinion should not participate.
研究者
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