NCT02260154已完成不适用
Effectiveness of Duspatalin® (Mebeverine Hydrochloride) 200 mg b.i.d. in Patients With Post-cholecystectomy Gastrointestinal Spasm: a Post Marketing Observational Program in the Russian Federation
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 220
- 试验地点
- 21
- 主要终点
- Percentage of "Responders" to Duspatalin® Therapy
研究概览
简要总结
Prospective, multicenter, non-comparative, observational program designed to assess the effectiveness of a 2-6 weeks treatment with Duspatalin® 200mg bis in die = twice a day (BID) and changes in quality of life in patients with post-cholecystectomy gastro-intestinal spasms
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female ≥ 18 years to 65 years;
- •Patients suffering from post-cholecystectomy GI-spasms in the last 3 months with symptom onset at least 6 months prior to inclusion and not requiring surgical treatment;
- •Laparoscopic cholecystectomy between 6 months to 5 years before enrollment;
- •Patients having been prescribed Duspatalin® (mebeverine) 200 mg BID (bis in die = twice a day) in accordance with approved local label;
- •Patient's written authorization to provide data for the program
排除标准
- •General and specific contraindications to Duspatalin® treatment according to the local label;
- •Planned Endoscopic Retrograde Cholangiopancreatography (ERCP) and/or surgical treatment;
- •Being currently treated or having been treated with Duspatalin® within the 6 weeks prior to entering the program;
- •Pregnancy or lactation;
- •Other conditions that make patient participation impossible (by investigator judgment);
- •Previous enrollment in the present program;
- •Treatment with other antispasmodics, pain-medication (Nonsteroidal anti-inflammatory drugs (NSAIDs), tramadol, etc.) within 2 weeks prior to inclusion into the observational study.
研究组 & 干预措施
Post-cholecystectomy gastrointestinal spasms
Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
干预措施: Mebeverine (Drug)
结局指标
主要结局
Percentage of "Responders" to Duspatalin® Therapy
时间窗: 2 weeks
Patients indicating being 'symptom-free' or 'markedly improved'on Global Patient Assessment
次要结局
- Percentage of "Responders" to Duspatalin® Therapy(Up to 6 weeks)
- Changes in Dyspepsia Symptoms(Baseline, 2 weeks and up to 6 weeks)
- Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form(Baseline to Week 2)
- Changes in Quality of Life(Baseline, 2 weeks and up to 6 weeks)
- Health Economic Data(Baseline, up to 6 weeks)
- Reasons for Continuing Treatment Beyond 2 Weeks(2 weeks)
- Healths Economic Data 2(from baseline at Week 6)
- Health Economics Data 3(change from baseline at Week 6)
- Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form 2(Baseline to Week 6)
- Changes in Abdominal Pain(Baseline, 2 weeks and up to 6 weeks)
研究者
研究点 (21)
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