EUCTR2004-003619-22-GB进行中（未招募）不适用
A placebo-controlled study to investigate the efficacy of a combination analgesic treatment compared to its individual components in primary dysmenorrhoea.
GlaxoSmithKline Consumer Healthcare0 个研究点目标入组 320 人开始时间: 2005年7月20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
- 320
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
- •Female subjects aged 18 years upwards.
- •Self-reported history of Grade 2 or 3 (Andersch and Milsom scoring system – Am J Obstet Gynecol 1982; 144:655-660) primary dysmenorrhoea.
- •?Grade 0 = menstruation is not painful, and daily activity is unaffected. OTC analgesics are not required.
- •?Grade 1 = menstruation is painful but seldom inhibits normal activity; OTC analgesics are seldom required; mild pain.
- •?Grade 2 = daily activity unaffected; OTC analgesics required and give sufficient relief so that absence from college or work is unusual; moderate pain
- •?Grade 3 = Activity clearly inhibited; poor effect of analgesics; vegetative symptoms (eg. headache, fatigue, nausea, backache); severe pain
- •At least 3 painful menstrual cycles during the previous 4 months which have required medication with OTC analgesics.
- •Duration of menstrual cycle within the range 21-35 days.
- •Onset of dysmenorrhoea < 3 years after menarche.
- •Patient known, by questioning, to have an adequate response to OTC analgesics in the treatment of dysmenorrhoea symptoms.
- •Otherwise good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination
- •Patients of childbearing potential must be practicing, in the opinion of the investigator, a reliable method of contraception and must be willing to continue on their method of contraception throughout the study
- •Patient should understand and is willing, able and likely to fully comply with all study procedures and restrictions
- •Patient gives voluntary 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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant or lactating or attempting to become pregnant
- •Recent history (within the last 2 years) of analgesic, alcohol or other substance abuse. Abuse is defined as self-reported, diagnosed or treated
- •Have known or suspected intolerance or hypersensitivity to the study treatments (paracetamol or caffeine) or any of their stated ingredients or any related compounds
- •Have known or suspected intolerance or hypersensitivity to ibuprofen (rescue medication)
- •Medical history which renders patient unable to take study treatments or rescue medication
- •?Severe liver or kidney disease (paracetamol)
- •?Current or history of stomach ulcer or other stomach disorder (ibuprofen)
- •?Asthma (ibuprofen)
- •Clinical Study/Experimental Medication
- •?Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study
- •?Previous participation in this study
- •An employee of the sponsor or the study site.
- •Positive urine screen for drugs of abuse
研究者
相似试验
终止
4 期
Acute Stroke Treatment with Atorvastatin and IrbesartaAcute Ischaemic StrokeStroke - IschaemicACTRN12605000170628niversity of Western Australia200
已完成
2 期
A placebo-controlled clinical trial to assess efficacy of tranexamic acid in reducing hemorrhage after vaginal deliverypostpartum hemorrhage.Haemorrhage following delivery of placentaIRCT201204079399N1Vice chancellor for research ,Kashan University of Medical Sciences200
进行中（未招募）
不适用
Placebo-controlled trial investigating the effect of Vitamin K3-lotion for the treatment of cetuximab induced folliculitis - Vitamin K3EUCTR2009-016591-68-DKOdense University Hospital36
Unknown
不适用
ight to fight addictiochronic alcohol dependencyNL-OMON24477Technische Universiteit Eindhoven60
已完成
不适用
A placebo-controlled trial to test the effectiveness of a lighting intervention to reduce or stabilize alcohol use and craving in alcohol dependent patientsNL-OMON49511Technische Universiteit Eindhoven60