A Randomized, Double Blind, Parallel Group, Placebo-controlled Study to Evaluate the Effect of On-demand Treatment With Asimadoline in Patients With Irritable Bowel Syndrome Over 4 Weeks
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Severity of abdominal pain 2 hours after treatment of pain
研究概览
简要总结
The treatment of acute pain in patients with irritable bowel symptoms is suboptimal. This is a placebo controlled study of the on demand treatment of pain experienced over a 4 week period in patients with irritable bowel syndrome. Patients will record the severity of pain when they take the study medication and two hours later.
详细描述
Background:
Asimadoline reduces visceral sensitivity in experimental animal models and has been tested for its effects on gastric sensorimotor function in healthy individuals. It reduces pain sensation in response to distensions that correspond to pressures frequently encountered in the human colon. However, the effects on improvement of pain and gastrointestinal symptoms in individuals with irritable bowel syndrome (IBS) are unclear.
Hypothesis:
The kappa opioid agonist, Asimadoline, reduces pain and discomfort and decreases gastrointestinal symptoms in participants with IBS.
Aim The aim is to compare the effects of Asimadoline (0.5 mg p.r.n, up to 1mg q.i.d.) and placebo on pain and discomfort and other gastrointestinal symptoms in patients with IBS.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Severity of abdominal pain 2 hours after treatment of pain
Average pain reduction within 2 hours after first dose each day ( pain intensity on VAS before and two hours after the first dose on each day with at least moderate pain)
The primary efficacy analysis includes all days with complete data sets for VAS before and two hours after intake of study medication and a before-treatment pain intensity of at least 30 mm on the VAS
For each of these days the pain reduction of the first dose will be calculated: PID (pain intensity difference) = Pain2h ? Pain0h
The average pain reduction on all these days will be calculated by: first, summing up all PID over the treatment period and second, dividing this result by the number of days with pain
次要结局
- Maximum pain during each day
- Frequency of bowel movements (number)
- Consistency of bowel movements (Bristol stool scale)
- Ease of passage
- Adequate relief of IBS pain and