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

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Rabelis DDR 50 mg Capsules
Pariet 20 mg Enteric Coated Tablets
Sponsored by
Neutec Ar-Ge San ve Tic A.Ş
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ege University Facult of Medicine Gastroenterology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rabelis DDR 50 mg Capsules and 1 placebo tablet

Pariet 20 mg Enteric Coated Tablets and 1 placebo capsule

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage time of 24-hour intragastric pH >4 compared to baseline
AUC of 24-hour intragastric pH >4 compared to baseline

Secondary Outcome Measures

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

Full Information

First Posted
January 27, 2017
Last Updated
December 11, 2018
Sponsor
Neutec Ar-Ge San ve Tic A.Ş
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1. Study Identification

Unique Protocol Identification Number
NCT03037606
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neutec Ar-Ge San ve Tic A.Ş

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rabelis DDR 50 mg Capsules and 1 placebo tablet
Arm Type
Experimental
Arm Description
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.
Arm Title
Pariet 20 mg Enteric Coated Tablets and 1 placebo capsule
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rabelis DDR 50 mg Capsules
Intervention Description
Rabelis DDR 50 mg Capsules once daily for seven days.
Intervention Type
Drug
Intervention Name(s)
Pariet 20 mg Enteric Coated Tablets
Intervention Description
Pariet 20 mg Enteric Coated Tablets once daily for seven days.
Primary Outcome Measure Information:
Title
Percentage time of 24-hour intragastric pH >4 compared to baseline
Time Frame
7 days
Title
AUC of 24-hour intragastric pH >4 compared to baseline
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Significant increase in total measurements of median pH
Time Frame
7 days
Title
Significant increase in nocturnal measurements of median pH
Time Frame
7 days
Title
Decrease in reflux symptom index calculated by weekly regurgitation numbers
Time Frame
7 days
Title
Decrease in reflux symptom index calculated by weekly pyrosis numbers
Time Frame
7 days
Title
Percentage time of 24-hour intragastric pH >2 compared to baseline
Time Frame
7 days
Title
Percentage time of 24-hour intragastric pH >6 compared to baseline
Time Frame
7 days
Title
AUC of 24-hour intragastric pH >2 compared to baseline
Time Frame
7 days
Title
AUC of 24-hour intragastric pH >6 compared to baseline
Time Frame
7 days
Title
Percentage time of 24-hour total intragastric pH >4 compared to baseline
Time Frame
7 days
Title
AUC of 24-hour total intragastric pH >4 compared to baseline
Time Frame
7 days
Title
Percentage time of 24-hour total intragastric pH >4 between 11 pm and 7 am compared to baseline baseline
Description
rate of night reflux
Time Frame
7 days
Title
AUC of of 24-hour total intragastric pH >4 between 11 pm and 7 am compared to baseline
Description
rate of night reflux
Time Frame
7 days
Title
The evaluation of safety of study drug (Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatments)
Time Frame
7 days
Title
Change in QT interval obtained by ECG compared to baseline
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Ege University Facult of Medicine Gastroenterology Department
City
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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