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Prucalopride Treatment for Refractory Gastro-esophageal Reflux Disease

GERD Clinical Trial

Official title:
A Placebo-controlled Trial With Prucalopride for the Treatment of Typical Reflux Symptoms in Patients With Gastro-esophageal Reflux Disease With Incomplete Proton Pump Inhibitor Response

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03676374
Study type Interventional
Source Universitaire Ziekenhuizen Leuven
Contact Hannelore Geysen
Phone +32 (0)16 324921
Email hannelore.geysen@kuleuven.be
Status Recruiting
Phase Phase 4
Start date February 18, 2019
Completion date April 2021
View Details
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