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.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516317-21-00

Enrollment

Registered

2024-10-10

Start date

2018-04-09

Completion date

Unknown

Last updated

2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastro-esophageal reflux disease

Brief summary

Change in acid exposure time assessed by 24 hour impedance-pH monitoring

Detailed description

Change in number of reflux episodes assessed by 24 hour impedance-pH monitoring, Change in motility patterns in the esophagus assessed by high resolution and impedance manometry, Change in symptom severity assessed by a reflux questionnaire (Request)

Interventions

DRUGPrucalopride Prolepha 2 mg filmomhulde tabletten

DRUGPlacebo tablet manufactured by Laboratoria Wolfs

DRUGZwijndrecht. Ingredients (1 tablet

DRUG488mg): Lactose monohydrate 320mg Carmellose sodium 10mg Corn starch 70mg Cellulose microcrystalline 55mg Silicium dioxide anhydrous 20mg Magnesium stearate 13mg

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change in acid exposure time assessed by 24 hour impedance-pH monitoring	—

Secondary

Measure	Time frame
Change in number of reflux episodes assessed by 24 hour impedance-pH monitoring, Change in motility patterns in the esophagus assessed by high resolution and impedance manometry, Change in symptom severity assessed by a reflux questionnaire (Request)	—

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026