Prucalopride Treatment for Refractory Gastro-esophageal Reflux Disease
Status:
Recruiting
Trial end date:
2021-04-01
Target enrollment:
Participant gender:
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.