EUCTR2022-000843-57-BG进行中（未招募）1 期
A double-blind, randomized, cross-over, multi-center efficacy and safety study of ibuprofen plus hyoscine butylbromide for pain management due to primary dysmenorrhea - Study of ibuprofen plus hyoscine butylbromide in patients with primary dysmenorrhoea
RONTIS HELLAS S.A.0 个研究点目标入组 54 人开始时间: 2022年8月26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
- 54
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 patients =18 and =40 years of age
- •[2]Patients with a history of primary dysmenorrhea
- •[3]Patients with moderate to severe pain in at least 5 of the last 6 menstrual cycles
- •[4]Patients willing and able (e.g., mental and physical condition) to participate in all aspects of the study as evidenced by providing signed written informed consent
- •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 54
- •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 hypersensitivity or intolerance to the active substances or any of the excipients of the study medication
- •[2]History of hypersensitivity reactions (e.g., asthma, urticaria, angioedema or rhinitis) after taking other NSAIDs (e.g., acetylsalicylic acid or similar)
- •[3]Any condition which might cause secondary dysmenorrhoea (e.g., endometriosis, salpingitis, adhesions)
- •[4]Other likely causes of abdominal pain (e.g., gastric or peptic ulcer, inflammatory bowel disease, leiomyoma, pelvic inflammatory disease)
- •[5]History of gastrointestinal bleeding
- •[6]Conditions involving an increased tendency to bleeding
- •[7]History of frequent dyspepsia, heartburn or indigestion
- •[8]Severe heart failure (NYHA Class IV), hepatic failure and renal failure
- •[9]Any of the following conditions:
- •a)untreated narrow angle glaucoma,
- •b)gastric outlet obstruction,
- •c)intestinal atony,
- •d)tachycardia,
- •e)mechanical stenosis of the gastrointestinal tract, myasthenia gravis,
- •f)megacolon
- •[10]History of significant disease deemed by the investigator to render the patients unsuitable for inclusion
- •[11]Concomitant major depression
- •[12]Concomitant condition that may interfere with the absorption, distribution, metabolism, or excretion of the study medication
- •[13]Previous (within 7 days before first study drug administration) intake or administration of analgesic, anti-inflammatory, antispasmodic or other therapy for dysmenorrhoea
- •[14]Previous (within 7 days before first study drug administration) intake or administration of medications that might confound the assessment of pain relief, such as psychotropic drugs, antidepressants, sedative-hypnotics, NSAIDs, muscle relaxants*
- •[15]Intake of oral contraceptives during the last 2 menstrual cycles preceding the trial
- •[16]Administration of hormonal contraceptive devices during the last 2 menstrual cycles preceding the trial
- •[17]Administration of long-acting depot contraceptives within the last 6 months preceding the trial
- •[18]Patient is currently enrolled in, or has completed less than 30 days before the screening examination of the present trial another clinical trial with an investigational drug
- •[19]Previous enrolment in this study
- •[20]Pregnant or breast-feeding women
- •[21]Women of childbearing potential unable or unwilling to undergo pregnancy tests and to practice adequate contraceptive measures. Reliable methods for women during the trial are:
- •a)combination of 2 barrier methods: female/male condoms, diaphragms, spermicides
- •b)surgical intervention (e.g., tubal ligation),
- •c)non-hormonal intrauterine device (IUD)
- •d)sexual abstinence
- •[22]Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
- •[23]Alcohol/drug dependence or abuse (excluding tobacco abuse)
- •[24]Unreliability or lack of cooperation
- •[25]Any other condition of the patient (e.g., serious or unstable medical or psychological condition, acute psychosis) that in the opinion of the investigator may compromise evaluation of the study treatment or may jeopardize patient’s safety, compliance or adherence to protocol requirements
研究者
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