A Placebo Controlled Trial With Baclofen for the Treatment of GERD Patients With Incomplete PPI Response
Status:
Completed
Trial end date:
2019-01-01
Target enrollment:
Participant gender:
Summary
Reflux (acid and non-acid) mainly occurs during transient LES relaxations (TLESRs). The
gamma-aminobutyric acid (GABA) receptor type B agonist baclofen was shown to inhibit TLESRs,
thereby significantly decreasing acid reflux after a meal in healthy controls and in patients
with GERD.
The primary objective of this study is to assess the efficacy (assessed by reflux symptom
questionnaire and pH-impedance recordings) of baclofen 10mg three times daily vs. placebo in
GERD patients with an incomplete response to PPI therapy.
The secondary objective is to assess the predictive value of reflux assessment (by
pH-impedance recordings) on the primary outcome.