A study to investigate the efficacy of prucalopride to treat typical reflux symptoms in patients with gastro-esophageal reflux disease

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

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004175-31-BE

Enrollment

Registered

2018-01-18

Start date

2018-04-09

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

refractory gastro-esophageal reflux disease

Interventions

Trade Name: Resolor 2mg Product Name: Resolor Pharmaceutical Form: Coated tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Pharmaceutical form of the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age between 18 and 65 - History of GERD symptoms during PPI treatment, at least 3 time per week for 12 weeks - Daily intake of PPI treatment 12 weeks prior to inclusion, with at least 8 weeks b.i.d. therapy - proven reflux on a 24 hour pH-impedance monitoring or esophagitis >grade A Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Systemic diseases, known to affect esophageal motility. - Colitis ulcerosa, Crohn’s disease, toxic megacolon. - Severely decreased kidney function. - Severely decreased liver function. - Surgery in the thorax or in the upper part of the abdomen. - Treatment with prucalopride prior to the start of the study. - Regular use of medications such as: anticholinergics, tricyclic antidepressants, baclofen, prokinetics. - Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator - Absence of PPI intake for at least 2 consecutive days in the 2 weeks prior to the screening. - Pregnancy or breast feeding.

Design outcomes

Primary

Measure	Time frame
Main Objective: - Efficacy of prucalopride for 4 weeks treatment on reflux parameters and symptoms in patients with gastro-esophageal reflux disease and an incomplete response to PPI therpay;Secondary Objective: Not applicable;Primary end point(s): - Change in reflux parameters assessed by 24 hour pH-impedance monitoring ;Timepoint(s) of evaluation of this end point: after 4 weeks of prucalopride intake	—

Measure

Time frame

Main Objective: - Efficacy of prucalopride for 4 weeks treatment on reflux parameters and symptoms in patients with gastro-esophageal reflux disease and an incomplete response to PPI therpay;Secondary Objective: Not applicable;Primary end point(s): - Change in reflux parameters assessed by 24 hour pH-impedance monitoring ;Timepoint(s) of evaluation of this end point: after 4 weeks of prucalopride intake

—

Secondary

Measure	Time frame
Secondary end point(s): - Change in symptoms severity assessed by a reflux questionnaire;Timepoint(s) of evaluation of this end point: after 4 weeks of prucalopride intake	—

Countries

Belgium

Contacts

Public ContactTARGID

TARGID, KU Leuven

hannelore.geysen@kuleuven.be32016324921

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026