Prucalopride Treatment for Refractory Gastro-esophageal Reflux Disease

Inclusion criteria

• ✓. 18 to 65 years old.
• ✓. 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.
• ✓. History of typical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks.
• ✓. 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).
• ✓. 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.
• ✓. 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