A Double-blind, Placebo-controlled, Cross-over Study Using Baclofen in the Treatment of Rumination Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Overall wellbeing of the patients, assessed by an overall treatment evaluation questionnaire.
研究概览
简要总结
Patients with a clinical suspicion of rumination syndrome and/or supra-gastric belching are randomized into baclofen or placebo for 2 weeks (10mg, tid). thereafter, they undergo a high resolution impedance manometry measurement, were they receive a solid meal, and recordings continue for another hour. Thereafter, they will receive the alternative treatment, after which they will undergo a second high resolution impedance manometry measurement. Patients are asked to fill out questionnaires during the entire study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical suspicion of rumination syndrome and/or supra-gastric belching.
- •Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception.
- •18 to 75 years old.
- •Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.
排除标准
- •Systemic diseases, known to affect esophageal motility.
- •Surgery in thorax or in the upper part of the abdomen.
- •Treatment with baclofen prior to the start of the study.
- •Significant neurological, respiratory, hepatic, renal, haematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.
- •Pregnancy or breast feeding.
- •History of poor compliance. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent. (well-controlled depression is allowed).
- •History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
研究组 & 干预措施
baclofen
Patients will receive baclofen (10mg t.i.d) for 2 weeks, thereafter they will be crossed over to the alternative treatment, which is placebo (identically looking capsules). After 2 weeks of treatment, patients will undergo a High Resolution Impedance Manometry (HRiM) measurement, with meal. We will record for in total 2 hours. Patients are asked to fill out questionnaires concerning their overall wellbeing.
干预措施: Baclofen (Drug)
placebo
Patients will receive placebo for 2 weeks, thereafter they will be crossed over to the alternative treatment, which is baclofen (10mg t.i.d) (identically looking capsules). After 2 weeks of treatment, patients will undergo a High Resolution Impedance Manometry (HRiM) measurement, with meal. We will record for in total 2 hours. Patients are asked to fill out questionnaires concerning their overall wellbeing.
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Overall wellbeing of the patients, assessed by an overall treatment evaluation questionnaire.
时间窗: 2 weeks treatment
patients fill out questionnaires concerning overall wellbeing, during the 2 weeks of treatment. Results of these questionnaires will be compared between both conditions (baclofen and placebo).
次要结局
- objective measurement of rumination / supra-gastric belching, using high resolution impedance manometry monitoring(2 weeks treatment)
研究者
Prof Dr Jan Tack
Professor
Universitaire Ziekenhuizen KU Leuven