Clinical Trial: Baclofen for Rumination
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double-blind, Placebo-controlled, Cross-over Study Using Baclofen in the Treatment of Rumination Syndrome
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 Summary:
Sponsor: Universitaire Ziekenhuizen Leuven
Current Primary Outcome: Overall wellbeing of the patients, assessed by an overall treatment evaluation questionnaire. [ Time Frame: 2 weeks treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome: objective measurement of rumination / supra-gastric belching, using high resolution impedance manometry monitoring [ Time Frame: 2 weeks treatment ]
Original Secondary Outcome: Same as current
Information By: Universitaire Ziekenhuizen Leuven
Dates:
Date Received: March 21, 2017
Date Started: February 1, 2012
Date Completion:
Last Updated: April 8, 2017
Last Verified: April 2017