Comparison of the Efficacy and Tolerability of Drotaverine 80 mg, Ibuprofen 400 mg and Their Combination in a Calendar Packaging for the Treatment of Primary and Secondary Dysmenorrhoea
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Reponse rate in each treatment arm: proportion of patients having pain intensity score 0 or 1 at hour 2 after the first drug intake.
研究概览
简要总结
The aim of the study is to show that the combination of drotaverine 80mg and ibuprofen 400 mg is more effective and as well-tolerated as ibuprofen 400 mg or drotaverine 80 mg administered alone, in the treatment of primary and secondary dysmenorrhoea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of at least 6 months of dysmenorrhea, with presence of moderate to severe pain in each of the last 3 cycles
- •With regular menstrual cycles (25-35 days)
- •Using an adequate barrier contraception method (except for virgins)
排除标准
- •Evidence of clinically relevant gynecological, cardiovascular, hematologic, hepatic, gastrointestinal, renal, pulmonary, endocrinologic, neurologic or psychiatric disease, based on a clinical assessment and routine laboratory investigations
- •Proven hypersensitivity to drotaverine hydrochloride or ibuprofen or proven intolerance to lactose
- •Any described contraindication to either drotaverine hydrochloride or ibuprofen (see Summary of Product Characteristics)
- •Oestro-progestative contraception within the last 2 months
- •Regular use of sedative, hypnotics, tranquillizers or any other addictive agents
- •History or evidence of acute or chronic alcohol abuse
- •Heavy smoking (> 10 cigarettes/day)
- •Need of a permanent treatment with other antispasmodics and/or analgesic agents during the trial
- •Lactation
- •Pregnancy
- •Participation in another clinical trial in the last 3 months prior to the start of this study
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
drotaverine + Ibuprofen placebo
Drotaverine 80 mg plus ibuprofen placebo orally
干预措施: Drotaverine (Drug)
drotaverine + Ibuprofen placebo
Drotaverine 80 mg plus ibuprofen placebo orally
干预措施: Ibuprofen Placebo (Drug)
Drotaverine placebo + ibuprofen
Drotaverine placebo plus ibuprofen 400 mg orally
干预措施: Drotaverine Placebo (Drug)
Drotaverine placebo + ibuprofen
Drotaverine placebo plus ibuprofen 400 mg orally
干预措施: Ibuprofen (Drug)
Drotaverine + ibuprofen
Drotaverine 80 mg plus ibuprofen 400 mg orally
干预措施: Drotaverine (Drug)
Drotaverine + ibuprofen
Drotaverine 80 mg plus ibuprofen 400 mg orally
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Reponse rate in each treatment arm: proportion of patients having pain intensity score 0 or 1 at hour 2 after the first drug intake.
次要结局
未报告次要终点