CTRI/2011/091/000141已完成3 期
A randomized, open label, comparative, multicentric, phase 3 clinical study to assess the efficacy and safety of Fixed dose combination tablets of Hyoscine butylbromide & Mefenamic acid in comparison with Hyoscine butylbromide tablets in patients suffering from paroxysmal spastic abdominal pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- The degree of improvement in the pain intensity score
研究概览
简要总结
This study is a randomized, open label, active controlled, multicentric study comparing the safety and efficacy of Hyoscine butylbromide 10 mg and Mefenamic acid 250 mg fixed dose combination tablets and Hyoscine butylbromide 10 mg tablets given 4 times daily for the entire study duration in 200 patients with paroxysmal spastic abdominal pain that will be conducted in India. The primary outcome measures will be the change in the pain intensity score during the course of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Day(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either sex of 18 to 60 years of age 2.Patients with clinical diagnosis of paroxysmal spastic abdominal pain 3.Informed consent.
排除标准
- •1.Pregnancy and/or Lactation2.Patients with pain of severe intensity who cannot be managed with oral medications3.Patients with peri-operative pain in the setting of CABG surgery4.Patients with current or history of peptic ulcer, gastrointestinal bleeding or inflammation5.Patients with history of cardiovascular thrombotic events or significant cardiovascular illness6.Patients with high grade fever, myasthenia gravis, megacolon, narrow angle glaucoma and those susceptible to intestinal or urinary outlet obstruction7.Patients with hepatic or renal impairment 8.Hypersensitivity to study medications9.Patients requiring concomitant treatment which is not permissible10.Patients with any other serious concurrent illness or malignancy11.Patients with continuing history of alcohol and / or drug abuse12.Participation in another clinical trial in the past 3 months.
结局指标
主要结局
The degree of improvement in the pain intensity score
时间窗: Daily for the entire study period
次要结局
- (1)The degree of improvement in pain relief score((2)The investigators? global assessment of efficacy)
研究者
研究点 (5)
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