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

Phase 1

• Conditions: refractory gastro-esophageal reflux disease; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2017-004175-31-BE
• Lead Sponsor: TARGID, KU Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-18
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified