A Placebo Controlled Trial With Baclofen for the Treatment of GERD Patients With Incomplete PPI Response

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.

Timeline

Start

2010-01

Primary completion

2016-12

Completion

2019-01

Drugs

Indications