Prucalopride Treatment for Refractory Gastro-esophageal Reflux Disease

GERD Clinical Trial

Official title:

A Placebo-controlled Trial With Prucalopride for the Treatment of Typical Reflux Symptoms in Patients With Gastro-esophageal Reflux Disease With Incomplete Proton Pump Inhibitor Response

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03676374
• Other study ID #: S61035
• Status: Recruiting
• Phase: Phase 4
• Start date: February 18, 2019
• Est. completion date: April 2021

Study information

• Verified date: December 2019
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Hannelore Geysen
• Phone: +32 (0)16 324921
• Email: hannelore.geysen[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Up to date there is no placebo-controlled trial to investigate the effect of prucalopride in patients with proven refractory GERD. Therefore, to evaluate the efficacy of prucalopride on the improvement in symptom severity and reflux parameters, we will conduct a randomized, parallel, placebo-controlled, single-blind study. 60 patients with refractory GERD symptoms will receive either placebo or prucalopride (Resolor®) 2 mg for a period of 4 weeks. Symptom severity will be assessed by a validated reflux questionnaire (ReQuest) and reflux parameters (acid exposure time and number of reflux episodes) will be assessed by means of a 24 hour impedance-pH monitoring.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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:

1. Systemic diseases, known to affect esophageal motility.

2. Colitis ulcerosa, Crohn's disease, toxic megacolon.

3. Have a cardiovascular disease or QT c>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. Major psychiatric disorder.

9. Treatment with prucalopride prior to the start of the study.

10. Concomitant use of medications such as: anticholinergics, baclofen or prokinetics.

11. Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.

12. Absence of PPI intake for at least 2 consecutive days in the 2 weeks prior to the screening.

13. Pregnancy or breast feeding.

14. History of poor compliance. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.

15. History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD

Intervention

Drug:
• Prucalopride
Prucalopride 2mg taken once a day as add-on to PPI (2x/d)
• Placebo Oral Tablet
Placebo tablet taken once a day as add-on to PPI (2x/d)

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in acid exposure time	change in acid exposure time assessed by 24 hour impedance-pH monitoring.	4 weeks
Secondary	change in number of reflux episodes	change in number of reflux episodes assessed by 24 hour impedance-pH monitoring	4 weeks
Secondary	Change in symptom severity	change in symptom severity assessed by a validated reflux questionnaire (ReQuest questionnaire and diaries)	4 weeks