Prucalopride for refractory gastro-esophageal reflux disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Trial duration

9 Apr 2018 → ongoing

Decision date (initial)

2024-10-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516317-21-00

EudraCT number

2017-004175-31

ClinicalTrials.gov

NCT03676374

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

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

Secondary objectives 1

1. To predict based on a 24h pH-impedance monitoring and validated questionnaires, which patients benefit from treatment with prucalopride 2mg

Conditions and MedDRA coding

gastro-esophageal reflux disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 18 to 65 years old.
2. 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.
3. History of typical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks.
4. 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).
5. 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.
6. 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 9

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in acid exposure time assessed by 24 hour impedance-pH monitoring

Secondary endpoints 3

1. Change in number of reflux episodes assessed by 24 hour impedance-pH monitoring
2. Change in motility patterns in the esophagus assessed by high resolution and impedance manometry
3. Change in symptom severity assessed by a reflux questionnaire (Request)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Jan Tack

Public contact point

Organisation

UZ Leuven

Contact name

Jan Tack

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications