Baclofen for Rumination

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-01

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Rumination Supra-gastric Belching

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Baclofen

Intervention Type DRUG

baclofen oral, 10mg, tid for 2 weeks (or placebo, identically looking capsules) after 2 weeks, patients undergo a High Resolution Impedance Manometry measurement with a meal period. Patients will fill out questionnaires concerning overall wellbeing.

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.

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

placebo oral, tid for 2 weeks after 2 weeks, patients undergo a High Resolution Impedance Manometry measurement with a meal period. Patients will fill out questionnaires concerning overall wellbeing.

Interventions

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Baclofen

baclofen oral, 10mg, tid for 2 weeks (or placebo, identically looking capsules) after 2 weeks, patients undergo a High Resolution Impedance Manometry measurement with a meal period. Patients will fill out questionnaires concerning overall wellbeing.

Intervention Type DRUG

Placebo oral capsule

placebo oral, tid for 2 weeks after 2 weeks, patients undergo a High Resolution Impedance Manometry measurement with a meal period. Patients will fill out questionnaires concerning overall wellbeing.

Intervention Type DRUG

Other Intervention Names

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Lioresal

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No