A Phase 4 interventional study of Baclofen and Placebo oral capsule in Rumination and Supra-gastric Belching, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-04-13.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 4, Interventional, and Treatment
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.
72 studies on the registry are indexed under Rumination Syndrome; 22 are open to participants now.
This study's enrollment of 20 is below the median of 62 across 63 interventional studies indexed under Rumination Syndrome.
Browse Rumination Syndrome studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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.
Drug: Baclofen
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.
Drug: Placebo oral capsule
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.
Also known as: Lioresal
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.
Overall wellbeing of the patients, assessed by an overall treatment evaluation questionnaire.
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).
Time frame: 2 weeks treatment
objective measurement of rumination / supra-gastric belching, using high resolution impedance manometry monitoring
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.
Time frame: 2 weeks treatment
No study locations are listed for this record.
Plan to share: Undecided
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Universitaire Ziekenhuizen KU Leuven