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Prucalopride Treatment for Refractory Gastro-esophageal Reflux Disease

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ClinicalTrials.gov Identifier: NCT03676374
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Prof Dr Jan Tack, Universitaire Ziekenhuizen Leuven

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

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)




Primary Outcome Measures :
  1. change in acid exposure time [ Time Frame: 4 weeks ]
    change in acid exposure time assessed by 24 hour impedance-pH monitoring.


Secondary Outcome Measures :
  1. change in number of reflux episodes [ Time Frame: 4 weeks ]
    change in number of reflux episodes assessed by 24 hour impedance-pH monitoring

  2. Change in symptom severity [ Time Frame: 4 weeks ]
    change in symptom severity assessed by a validated reflux questionnaire (ReQuest questionnaire and diaries)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676374


Contacts
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Contact: Hannelore Geysen +32 (0)16 324921 hannelore.geysen@kuleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Hannelore Geysen    +32 (0)16 324921    hannelore.geysen@kuleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven

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Responsible Party: Prof Dr Jan Tack, Prof. Dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03676374     History of Changes
Other Study ID Numbers: S61035
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Prucalopride
Molecular Mechanisms of Pharmacological Action
Laxatives
Gastrointestinal Agents
Serotonin 5-HT4 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs