Clinical trial NCT03037606: Comparison of the Effect of Rabeprazole 50 mg DDR Capsules and 20 mg Enteric-coated Tablets
Official title: Comparison of the Effect of Rabeprazole 50 mg DDR Capsules and 20 mg Enteric-coated Tablets on Intragastric and Intraesophageal Acidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Neutec Ar-Ge San ve Tic A.Ş
Sponsor class: INDUSTRY
First posted: 2017-01-31
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is planned to compare the efficacy and safety of rabeprazole 50 mg DDR (dual delayed release) capsules versus rabeprazole 20 mg enteric coated tablets administered once daily in patients with Gastroesophageal Reflux Disease (GERD).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of GERD with symptoms (i.e. regurgitation, pyrosis) at least 1 or more episodes a week.
* Age ≥ 18 years and \<65 years
* Helicobacter pylori (an infection) negative
* Have a body mass index (BMI) between 18 and 33 kg/m²
* pH\>4 gastric exposure \<25% on a 24-hour dual pH channel monitoring study performed prior to screening (normal intragastric pH +2SD)
* Pathologic intraesophageal acidity exposure (DeMeester score \>14.75 and/or \>4% of pH\<4 (at least 21 hours measured)

Exclusion Criteria:

* Patiets with Barrett's stricture, gastric outlet obstruction, malignancy, gastrointestinal system bleeding or any other upper gastrointestinal system pathology.
* Patients whose Hiatus hernia is \> 3 cm.
* Patients with uncontrolled or insulin dependent diabetes mellitus, symptomatic gallbladder stone, active or unhealed stomach or duodenum ulcer, Zollinger-Ellison syndrome, primary esophagus motility disorder, pancreatitis, inflammatory bowel disease, severe lung disease, chronic liver disease, uncontrolled kidney impairment, cancer (except skin cancer except melanoma), cerebrovascular disease, epilepsy.
* Patients with history of heart failure, ventricular tachycardia, ventricular fibrillation, cardiac arrest, Torsades de pointes, bradycardia, sinus node dysfunction, heart attack, long QTc (\>450 ms for male, \>470 ms for female patients).
* Patients taken PPIs or H2-blockers within 7 days and prokinetic drugs within 3 days before entering the study.
* Patients with major psychiatric disease.
* Alcoholism and drug use.
* Patients with pathologic laboratory tests; hemogram, sedimentation, CRP, thyroid functions tests, liver enzymes.
* Malabsorbtion.
* Immunosuppressive patients.
* Patients taken cortisone.
* Patients taken other drugs that prolong QT interval.
* Patients taken drugs that need gastric acid for optimal absorption; ketoconazole, iron salts, digoxin, ampicillin esters, anticoagulants, antineoplastic agents, prostaglandin analogues, sukralfat.
* Pregnancy or breast-feeding.
* Patients taken drugs that may affect gastrointestinal system motility or acid release.
* History of abdominal surgery (hysterectomy, abdominal hernia repair, caesarean cases may be included; cholecystectomy have to be excluded).
* Patients taken NSAII drugs (paracetemol may be used up to 2 gr/day).
* Patients taken antidepressants.
* Hypersensitivty to study drugs.
* Known allergy to peanut and soy.

Primary outcomes:
measure: Percentage time of 24-hour intragastric pH >4 compared to baseline
timeFrame: 7 days
measure: AUC of 24-hour intragastric pH >4 compared to baseline
timeFrame: 7 days
Secondary outcomes:
measure: Significant increase in total measurements of median pH
timeFrame: 7 days
measure: Significant increase in nocturnal measurements of median pH
timeFrame: 7 days
measure: Decrease in reflux symptom index calculated by weekly regurgitation numbers
timeFrame: 7 days
measure: Decrease in reflux symptom index calculated by weekly pyrosis numbers
timeFrame: 7 days
measure: Percentage time of 24-hour intragastric pH >2 compared to baseline
timeFrame: 7 days
measure: Percentage time of 24-hour intragastric pH >6 compared to baseline
timeFrame: 7 days
measure: AUC of 24-hour intragastric pH >2 compared to baseline
timeFrame: 7 days
measure: AUC of 24-hour intragastric pH >6 compared to baseline
timeFrame: 7 days
measure: Percentage time of 24-hour total intragastric pH >4 compared to baseline
timeFrame: 7 days
measure: AUC of 24-hour total intragastric pH >4 compared to baseline
timeFrame: 7 days
measure: Percentage time of 24-hour total intragastric pH >4 between 11 pm and 7 am compared to baseline baseline
timeFrame: 7 days
measure: AUC of of 24-hour total intragastric pH >4 between 11 pm and 7 am compared to baseline
timeFrame: 7 days
measure: The evaluation of safety of study drug (Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatments)
timeFrame: 7 days
measure: Change in QT interval obtained by ECG compared to baseline
timeFrame: 21 days
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University Facult of Medicine Gastroenterology Department
Study officials:
References: