NCT02229786已完成2 期
Buscopan® Plus, Buscopan®, Paracetamol and Placebo: Double-blind Randomized Group Comparison to Investigate the Efficacy and Tolerability of the Film-coated Tablets in Patients With Painful Gastric or Intestinal Spasms
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,637
- 主要终点
- Mean decrease in pain intensity on a VAS (visual analog scale)
研究概览
简要总结
Study to evaluate efficacy and tolerability of Buscopan® plus versus Buscopan®, paracetamol, and placebo in patients with painful gastric or intestinal spasms.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients
- •Age: 18 - 70 years
- •Diagnosis: recurring painful gastric or intestinal spasms such as occur e.g. in irritable bowel syndrome, which are not organic in origin, have been present for at least 2 months, and are serious enough to interfere with everyday activities
- •Patient briefing as per §§ 40/41 of the Arzneimittelgesetz (AMG) and patient's declaration of Informed Consent in writing, in agreement with Good Clinical Practice (GCP) and current legal requirements
- •A pain assessment of 3 cm or more on the visual analog scale on at least one of the 2 days immediately preceding the second visit
排除标准
- •Painful gastric or intestinal spasms of organic origin such as Crohn's disease, ulcerative colitis, lactose intolerance
- •Tumour pain/malignant growths
- •Patients with other severe pain states of organic origin (e.g. biliary colic)
- •Mechanical stenoses of the gastrointestinal tract, megacolon
- •Urinary retention associated with mechanical stenoses of the urinary tract (e.g. in prostate adenoma)
- •Narrow-angle glaucoma
- •Tachyarrhythmia
- •Myasthenia gravis
- •Glucose 6-phosphate dehydrogenase deficiency (danger of haemolytic anaemia)
- •Known hypersensitivity to N-butylscopolammonium bromide or paracetamol
- •Severe liver impairment (e.g. through chronic alcohol abuse, hepatitis):
- •a) Serum-Glutamate-Oxalacetat-Transaminase/ Aspartate Aminotransferase (SGOT) higher than four times the norm
- •b) Bilirubin > 3 mg/dl
- •c) Quick's value < 70%
- •Meulengracht-Gilbert syndrome (metabolic disturbance with episodes of jaundice)
- •Severe kidney failure: creatinine > 2 mg/dl
- •Known depression or known mental illness, anxiety disturbance
- •Concomitant intake of analgesics, nonsteroidal antiinflammatory drugs (NSAIDs) and/or spasmolytics, anticholinergics, nitrates
- •Concomitant medication affecting gastrointestinal motility
- •Regular (daily) use of laxatives
- •Drugs that induce liver enzymes
- •Concomitant administration of chloramphenicol
- •Use of narcotics
- •Antidepressant treatment or treatment with psychoactive drugs
- •Pregnancy and lactation
- •Alcohol abuse (more than 60 g alcohol/day)
- •Frequent vomiting that might prevent adequate absorption of the active ingredient after the film-coated tablet is taken
- •Patients who are unlikely to be able to keep the examination appointments or cannot reliably take the study medication regularly
- •Simultaneous participation in another clinical study
- •Patients who are not trained in the VAS (PI) at Visit 1
研究组 & 干预措施
Buscopan® plus
Experimental
干预措施: Buscopan® plus (Drug)
Buscopan®
Active Comparator
干预措施: Buscopan® (Drug)
Paracetamol
Active Comparator
干预措施: Paracetamol (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mean decrease in pain intensity on a VAS (visual analog scale)
时间窗: 3 weeks
次要结局
- Frequency of pain on a 4-stage verbal rating scale(up to 4 weeks)
- Global assessment of efficacy by patient on a 5-point rating scale(up to 4 weeks)
- Global assessment of efficacy by investigator on a 5-point rating scale(up to 4 weeks)
- Number of patients with adverse events(up to 4 weeks)
研究者
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