Baclofen for Rumination

Phase 4

Completed

• Conditions: Rumination; Supra-gastric Belching
• Interventions: Drug: Placebo oral capsule; Drug: Baclofen

• Registration Number: NCT03113396
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-01
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Study First Submitted: 2017-03-21
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-08
• Last Update Submitted: 2017-04-08
• Study First Posted: 2017-04-13
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	Placebo oral capsule	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.
baclofen	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.

Primary Outcome Measures

Name	Time	Method
Overall wellbeing of the patients, assessed by an overall treatment evaluation questionnaire.	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).

Secondary Outcome Measures

Name	Time	Method
objective measurement of rumination / supra-gastric belching, using high resolution impedance manometry monitoring	2 weeks treatment	High Resolution impedance Manometry monitoring will be performed, with a meal. We will look at the number of times patients push an event marker, the number of time patients ruminate or have supra-gastric belching or have reflux episodes, or have transient lower esophageal sphincter relaxations, both before and after the meal. And we will compare these outcomes between placebo and baclofen.