PRUCALOPRIDE for Gastro-oesophageal reflux disease

Inclusion criteria

• {"criterion_text":"- 18 to 65 years old."}
• {"criterion_text":"- Patients must have proven reflux, documented either by the presence of esophagitis (≥ grade B) at upper endoscopy (“on” PPI b.i.d.) in the 24 months prior to inclusion or pathological reflux parameters (acid exposure time >4% or number of reflux episodes >40) on a 24 hour impedance-pH monitoring (“on” PPI b.i.d.) in the 6 months prior to inclusion."}
• {"criterion_text":"- History of typical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks."}
• {"criterion_text":"- Daily intake of PPI treatment 12 weeks prior to inclusion, with at least 8 weeks of b.i.d. therapy (at least 2*20mg of omeprazole or equivalent)."}
• {"criterion_text":"- Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception do not include oral contraceptives, due to expected diarrhea as side effect of prucalopride. Injectable or implantable methods, intrauterine devices, or properly used barrier contraception are acceptable forms of contraception."}
• {"criterion_text":"- Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed."}

Exclusion criteria

• {"criterion_text":"- Systemic diseases, known to affect esophageal motility."}
• {"criterion_text":"- Colitis ulcerosa, Crohn’s disease, toxic megacolon."}
• {"criterion_text":"- Have a cardiovascular disease or QTc >450 ms"}
• {"criterion_text":"- Severely decreased kidney function."}
• {"criterion_text":"- Severely decreased liver function."}
• {"criterion_text":"- Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed)."}
• {"criterion_text":"- Number of stools >3 per day."}
• {"criterion_text":"- Treatment with prucalopride prior to the start of the study."}
• {"criterion_text":"- Concomitant use of medications such as: anticholinergics, baclofen or prokinetics."}

Primary endpoints

• {"endpoint_text":"- Change in acid exposure time assessed by 24 hour impedance-pH monitoring","definition_or_measurement_approach":"Assessed by 24 hour impedance-pH monitoring (change in acid exposure time)."}

Secondary endpoints

• {"endpoint_text":"- Change in number of reflux episodes assessed by 24 hour impedance-pH monitoring","definition_or_measurement_approach":"Assessed by 24 hour impedance-pH monitoring (change in number of reflux episodes)."}
• {"endpoint_text":"- Change in motility patterns in the esophagus assessed by high resolution and impedance manometry","definition_or_measurement_approach":"Assessed by high resolution and impedance manometry (change in esophageal motility patterns)."}
• {"endpoint_text":"- Change in symptom severity assessed by a reflux questionnaire (Request)","definition_or_measurement_approach":"Assessed using a reflux questionnaire (REQUEST) to measure change in symptom severity."}

Belgium

Earliest CTIS Part Ii Submission Date

09-10-2024

Latest Decision Or Authorization Date

10-10-2024

Processing Time Days

1

Number Of Sites

3

Number Of Participants

60

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium