BridgeMD
Prucalopride for refractory gastro-esophageal reflux disease
EU CTIS ID: 2024-516317-21-00
What this study is testing
To assess the efficacy of prucalopride 2mg 4 weeks add-on treatment in patients with gastro-esophageal reflux disease and an incomplete response to PPI therapy
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Systemic diseases, known to affect esophageal motility.
- Colitis ulcerosa, Crohn’s disease, toxic megacolon.
- Have a cardiovascular disease or QTc >450 ms
- Severely decreased kidney function.
- Severely decreased liver function.
- Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed).
See the full eligibility 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.
- Systemic diseases, known to affect esophageal motility.
- Colitis ulcerosa, Crohn’s disease, toxic megacolon.
- Have a cardiovascular disease or QTc >450 ms
- Severely decreased kidney function.
- Severely decreased liver function.
- Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed).
- Number of stools >3 per day.
- Treatment with prucalopride prior to the start of the study.
- Concomitant use of medications such as: anticholinergics, baclofen or prokinetics.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.