Prucalopride Treatment for Refractory Gastro-esophageal Reflux Disease

Summary

Up to date there is no placebo-controlled trial to investigate the effect of prucalopride in patients with proven refractory GERD. Therefore, to evaluate the efficacy of prucalopride on the improvement in symptom severity and reflux parameters, we will conduct a randomized, parallel, placebo-controlled, single-blind study. 60 patients with refractory GERD symptoms will receive either placebo or prucalopride (Resolor®) 2 mg for a period of 4 weeks. Symptom severity will be assessed by a validated reflux questionnaire (ReQuest) and reflux parameters (acid exposure time and number of reflux episodes) will be assessed by means of a 24 hour impedance-pH monitoring.

Timeline

Start

2019-02-18

Primary completion

2021-04

Completion

2021-04

Drugs

Indications