EUCTR2018-000138-37-ES进行中（未招募）1 期
PHASE III CLINICAL TRIAL FOR THE EVALUATION OF THE EFFICACY AND SAFETY OF A PARACETAMOL + IBUPROFEN COMBINATION IN PATIENTS WITH PRIMARY DYSMENORRHOEA
aboratorios Farmalíder S.A.0 个研究点目标入组 480 人开始时间: 2018年2月15日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 480
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) Female subjects able to understand and sign the informed consent to participate in the trial after having received information about the study design, the objectives of the project, the possible derivative risks, and the right to deny their collaboration at any time throughout the study
- •2) Females aged > 18 years.
- •3) Primary Dysmenorrhoea with moderate or severe pain, with pain score higher or equal than 50 mm in the Visual Assessment Scale (VAS = 50 mm)
- •4) At least four menstrual painful periods in the last six months that has needed analgesic treatment.
- •5) Regular menstrual cycle (28 ± 7 days).
- •6) Clinical History, physical examination and laboratory results without clinically relevant alterations.
- •7) Women who commit to use a reliable method of contraception, in opinion of the investigators, throughout the study.
- •8) Who agree not to take other analgesic drug different from the study drugs or the rescue medication during the study (until 72 hours after the first study drug administration).
- •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 480
- •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 drugs, including rescue medication or any other NSAID or their excipients.
- •2) History of bronchial asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria or angioneurotic edema.
- •3) History of peptic ulcer, NSAID gastrointestinal adverse reactions, gastrointestinal bleeding or other active bleeding disorders.
- •4) Moderate or severe hepatic, renal or cardiac active diseases.
- •5) Active disorders of blood coagulation.
- •6) Uncontrolled Epilepsy.
- •7) Ulcerative colitis or Crohn´s disease.
- •8) History of drug or alcohol abuse or dependency. Alcohol dependency must be considered as a weekly alcohol consumption of more than 14 units or a daily consumption of more than 2 units (One unit corresponds to 125 mL wine, 200 mL beer or 25 mL spirits).
- •9) Patients unable to abstain of alcohol, psychotropic or sedative drugs (i.e. benzodiazepines) or other forbidden medicines (see below) at least 48 hours or five elimination half-lives before or 24 h alter drug study administration. Forbidden drugs are NSAIDs other than those of the study, anticoagulants, thrombolytics and platelet antiaggregants, corticoids, MAO inhibitors, antipsychotics, antiepileptic drugs, SSRI, tricyclic antidepressants, sulfamides, methotrexate and lithium.
- •10) Patients who have taken any analgesic, anti-inflammatory, antispasmodic or other treatment for dysmenorrhoea within six hours before study drug administration.
- •11) Participants in any clinical trial (with experimental drugs or experimental medical devices) within the 30 days before the screening process.
- •12) Pregnant or lactating women.
- •13) History of any medical condition which in the opinion of investigators, may constitute a risk for the patient, or modify the study results.
- •14) Subjects who cannot meet the requirements of the study or that in the opinion of the researchers cannot participate.
研究者
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