Prucalopride Treatment for Refractory Gastro-esophageal Reflux Disease

NCT03676374 | Unknown Phase 4

• 1 other identifier: S61035
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

GERD

Outcome Measures

Primary Outcomes (1)

• change in acid exposure time

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

  4 weeks

Secondary Outcomes (2)

• change in number of reflux episodes

  4 weeks

• Change in symptom severity

  4 weeks

Study Arms (2)

Prucalopride

EXPERIMENTAL

Prucalopride 2mg once a day as add-on for PPI 2x/d

Drug: Prucalopride

Placebo

PLACEBO COMPARATOR

Placebo once a day as add-on for PPI 2x/d

Drug: Placebo Oral Tablet

Interventions

Prucalopride DRUG

Prucalopride 2mg taken once a day as add-on to PPI (2x/d)

Prucalopride

Placebo Oral Tablet DRUG

Placebo tablet taken once a day as add-on to PPI (2x/d)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years old.
• History of typical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks.
• 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 may not qualify if:

• Systemic diseases, known to affect esophageal motility.
• Colitis ulcerosa, Crohn's disease, toxic megacolon.
• Have a cardiovascular disease or QT c\>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.
• Major psychiatric disorder.
• Treatment with prucalopride prior to the start of the study.
• Concomitant use of medications such as: anticholinergics, baclofen or prokinetics.
• Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.
• Absence of PPI intake for at least 2 consecutive days in the 2 weeks prior to the screening.
• Pregnancy or breast feeding.
• History of poor compliance. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
• History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

prucalopride

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Hannelore Geysen

CONTACT

+32 (0)16 324921; hannelore.geysen@kuleuven.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: September 18, 2018
• Study Start: February 18, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: December 5, 2019

Record last verified: 2019-12

Locations

BE (1)