Comparison of the Effect of Rabeprazole 50 mg DDR Capsules and 20 mg Enteric-coated Tablets

Comparison of the Effect of Rabeprazole 50 mg DDR Capsules and 20 mg Enteric-coated Tablets on Intragastric and Intraesophageal Acidity

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).

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Drug: Rabelis DDR 50 mg Capsules; Drug: Pariet 20 mg Enteric Coated Tablets

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey, 35100
    • Ege University Facult of Medicine Gastroenterology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rabelis DDR 50 mg Capsules and 1 placebo tablet; Placebo as comparator group is not used. Since study is double-blind, one placebo capsule and tablet is added to treatment groups in order to remove the discrepancy between investigational products.	Drug: Rabelis DDR 50 mg Capsules; Rabelis DDR 50 mg Capsules once daily for seven days.
Active Comparator: Pariet 20 mg Enteric Coated Tablets and 1 placebo capsule; Placebo as comparator group is not used. Since study is double-blind, one placebo capsule and tablet is added to treatment groups in order to remove the discrepancy between investigational products.	Drug: Pariet 20 mg Enteric Coated Tablets; Pariet 20 mg Enteric Coated Tablets once daily for seven days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage time of 24-hour intragastric pH >4 compared to baseline	7 days
AUC of 24-hour intragastric pH >4 compared to baseline	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Significant increase in total measurements of median pH		7 days
Significant increase in nocturnal measurements of median pH		7 days
Decrease in reflux symptom index calculated by weekly regurgitation numbers		7 days
Decrease in reflux symptom index calculated by weekly pyrosis numbers		7 days
Percentage time of 24-hour intragastric pH >2 compared to baseline		7 days
Percentage time of 24-hour intragastric pH >6 compared to baseline		7 days
AUC of 24-hour intragastric pH >2 compared to baseline		7 days
AUC of 24-hour intragastric pH >6 compared to baseline		7 days
Percentage time of 24-hour total intragastric pH >4 compared to baseline		7 days
AUC of 24-hour total intragastric pH >4 compared to baseline		7 days
Percentage time of 24-hour total intragastric pH >4 between 11 pm and 7 am compared to baseline baseline	rate of night reflux	7 days
AUC of of 24-hour total intragastric pH >4 between 11 pm and 7 am compared to baseline	rate of night reflux	7 days
The evaluation of safety of study drug (Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatments)		7 days
Change in QT interval obtained by ECG compared to baseline		21 days

Collaborators and Investigators

• Sponsor: Neutec Ar-Ge San ve Tic A.Ş

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 11, 2018

Study Registration Dates

• First Submitted: January 27, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: NEU-03.16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No