Study of prucalopride in patients with gastro-esophageal reflux disease who have incomplete response to standard acid-reducing therapy

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What is this study about?

This study focuses on treating gastro-esophageal reflux disease (a condition where stomach acid frequently flows back into the food pipe, causing heartburn and other symptoms) in patients who do not get complete relief from standard acid-reducing medications. The study will test whether adding prucalopride, given as a 2 mg film-coated tablet, can help improve symptoms in these patients.

The purpose of this research is to determine if prucalopride, when added to existing acid-reducing therapy, can help reduce acid reflux in patients whose symptoms are not fully controlled by standard treatment. The study will compare prucalopride tablets to placebo tablets over a period of 4 weeks while patients continue their regular acid-reducing medication.

During the study, participants will take either prucalopride or placebo once daily for 8 weeks. Various tests will be performed to measure the amount of acid reflux and how well the food pipe is working. Participants will also complete questionnaires about their symptoms. The total amount of prucalopride that could be taken during the study period will not exceed 150 mg.

1 Initial assessment

Your participation begins with confirmation of gastro-esophageal reflux disease (GERD) diagnosis through previous medical documentation.

The medical team will verify your current proton pump inhibitor (PPI) treatment, which must have been taken daily for at least 12 weeks, with 8 weeks of twice-daily dosing.

2 Baseline measurements

You will undergo a 24-hour impedance-pH monitoring test to measure acid levels in your esophagus.

A high-resolution impedance manometry will be performed to evaluate how your esophagus muscles work.

You will complete a reflux questionnaire to assess your symptom severity.

3 Treatment period

You will receive either prucalopride 2mg tablets or placebo tablets (tablets without active medication).

The treatment duration is 4 weeks.

The medication should be taken orally according to the provided schedule.

You will continue your regular PPI medication during this period.

4 Final assessment

After 4 weeks, you will repeat the same tests performed at baseline:

– 24-hour impedance-pH monitoring

– High-resolution impedance manometry

– Reflux questionnaire completion

Who Can Join the Study?

Age between 18 and 65 years old
Must have confirmed reflux, proven by either:
- Presence of esophagitis (inflammation of the food pipe) grade B or higher, shown on endoscopy while taking PPI medication twice daily in the past 24 months, or
- Abnormal reflux test results from a 24-hour monitoring test performed in the last 6 months while taking PPI medication twice daily
Must have experienced typical reflux symptoms at least 3 times per week for 12 weeks while taking PPI medication
Must have been taking PPI medication daily for at least 12 weeks before joining the study, including at least 8 weeks of twice-daily therapy (minimum dose equivalent to omeprazole 20mg twice daily)
Women who can become pregnant and are sexually active must use appropriate birth control methods:
- Acceptable methods include: injectable contraceptives, implants, intrauterine devices, or barrier methods
- Oral contraceptives are not allowed due to possible interaction with study medication
Must be able to understand and willing to sign an informed consent form before any study procedures begin

Who Cannot Join the Study?

History of allergic reactions to prucalopride or similar medications
Pregnant or breastfeeding women
Current gastrointestinal disorders other than reflux disease (such as inflammatory bowel disease, Crohn’s disease, or ulcerative colitis)
History of major gastrointestinal surgery in the past 3 months
Current use of medications that might interact with the study drug
Severe liver or kidney problems
Uncontrolled high blood pressure or significant heart problems
History of cancer within the past 5 years (except for successfully treated skin cancer)
Current participation in other clinical trials
Unable to follow study procedures or attend scheduled visits
History of psychiatric conditions that might affect study participation
Substance abuse or alcohol dependency within the past year

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country	Status
Vrije Universiteit Brussel	Jette	Belgium
Umfnavhcou Oj Aslxszt	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.10.2018

Trial locations

Investigated drugs:

Prucalopride

Prucalopride is a medication used to improve symptoms in patients with gastro-esophageal reflux disease (GERD) who don’t get complete relief from standard acid-reducing medications. It works by improving the movement of food and acid through the digestive system. This medication is being tested as an additional treatment for patients who still experience reflux symptoms despite taking proton pump inhibitors (PPIs).

Proton Pump Inhibitors (PPIs) are medications that reduce stomach acid production. They are commonly used as a standard treatment for acid reflux and GERD. These medications work by blocking the cells in the stomach that produce acid, helping to reduce heartburn and other reflux symptoms.

Investigated diseases:

Gastrooesophageal reflux disease

Gastroesophageal Reflux Disease – A digestive disorder that occurs when stomach acid frequently flows back into the esophagus, the tube connecting the mouth and stomach. This backflow happens when the lower esophageal sphincter, a ring of muscle that acts as a valve between the esophagus and stomach, becomes weak or relaxes when it shouldn’t. The condition typically causes heartburn and regurgitation of food or sour liquid. Over time, this acid reflux can irritate and inflame the lining of the esophagus, leading to discomfort and other symptoms. The condition can affect people of all ages and often occurs after meals or when lying down.

Trial ID:

2024-516317-21-00

NCT ID:

NCT03676374

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of prucalopride in patients with gastro-esophageal reflux disease who have incomplete response to standard acid-reducing therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?