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Prucalopride Treatment for Refractory Gastro-esophageal Reflux Disease

NCT03676374 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-12-05

No results posted yet for this study

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.

Conditions

  • GERD

Interventions

DRUG

Prucalopride

Prucalopride 2mg taken once a day as add-on to PPI (2x/d)

DRUG

Placebo Oral Tablet

Placebo tablet taken once a day as add-on to PPI (2x/d)

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-18
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03676374 on ClinicalTrials.gov