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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

Tracking Information
First Submitted Date  ICMJE April 10, 2018
First Posted Date  ICMJE September 18, 2018
Last Update Posted Date December 12, 2018
Estimated Study Start Date  ICMJE December 2018
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2018)
change in acid exposure time [ Time Frame: 4 weeks ]
change in acid exposure time assessed by 24 hour impedance-pH monitoring.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03676374 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2018)
  • change in number of reflux episodes [ Time Frame: 4 weeks ]
    change in number of reflux episodes assessed by 24 hour impedance-pH monitoring
  • Change in symptom severity [ Time Frame: 4 weeks ]
    change in symptom severity assessed by a validated reflux questionnaire (ReQuest questionnaire and diaries)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prucalopride Treatment for Refractory Gastro-esophageal Reflux Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE GERD
Intervention  ICMJE
  • Drug: Prucalopride
    Prucalopride 2mg taken once a day as add-on to PPI (2x/d)
  • Drug: Placebo Oral Tablet
    Placebo tablet taken once a day as add-on to PPI (2x/d)
Study Arms  ICMJE
  • Experimental: Prucalopride
    Prucalopride 2mg once a day as add-on for PPI 2x/d
    Intervention: Drug: Prucalopride
  • Placebo Comparator: Placebo
    Placebo once a day as add-on for PPI 2x/d
    Intervention: Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 17, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hannelore Geysen +32 (0)16 324921 hannelore.geysen@kuleuven.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03676374
Other Study ID Numbers  ICMJE S61035
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof Dr Jan Tack, Universitaire Ziekenhuizen Leuven
Study Sponsor  ICMJE Universitaire Ziekenhuizen Leuven
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP