Prucalopride Treatment for Refractory Gastro-esophageal Reflux Disease

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03676374
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 25.4
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
GERD	Drug: Prucalopride; Drug: Placebo Oral Tablet	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 18, 2019
• Anticipated Primary Completion Date: Apr 1, 2021
• Anticipated Study Completion Date: Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prucalopride Prucalopride 2mg once a day as add-on for PPI 2x/d	Drug: Prucalopride; Prucalopride 2mg taken once a day as add-on to PPI (2x/d)
Placebo Comparator: Placebo Placebo once a day as add-on for PPI 2x/d	Drug: Placebo Oral Tablet; Placebo tablet taken once a day as add-on to PPI (2x/d)

Outcome Measures

Primary Outcome Measures

1. change in acid exposure time [4 weeks]

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

Secondary Outcome Measures

1. change in number of reflux episodes [4 weeks]

   change in number of reflux episodes assessed by 24 hour impedance-pH monitoring

2. Change in symptom severity [4 weeks]

   change in symptom severity assessed by a validated reflux questionnaire (ReQuest questionnaire and diaries)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. on a 24 hour impedance-pH monitoring ("on" PPI b.i.d.) in the 6 months prior to inclusion.

1. History of typical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks.

2. 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).

3. 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.

4. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Leuven	Leuven		Belgium	3000

Sponsors and Collaborators

• Universitaire Ziekenhuizen Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof Dr Jan Tack, Prof. Dr., Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT03676374
• Other Study ID Numbers: S61035
• First Posted: Sep 18, 2018
• Last Update Posted: Dec 5, 2019
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastroesophageal Reflux; Prucalopride

Study Results

No Results Posted as of Dec 5, 2019