Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03037606
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Neutec Ar-Ge San ve Tic A.Ş

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).

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: Rabelis DDR 50 mg Capsules Drug: Pariet 20 mg Enteric Coated Tablets Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of the Effect of Rabeprazole 50 mg DDR Capsules and 20 mg Enteric-coated Tablets on Intragastric and Intraesophageal Acidity
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

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.




Primary Outcome Measures :
  1. Percentage time of 24-hour intragastric pH >4 compared to baseline [ Time Frame: 7 days ]
  2. AUC of 24-hour intragastric pH >4 compared to baseline [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Significant increase in total measurements of median pH [ Time Frame: 7 days ]
  2. Significant increase in nocturnal measurements of median pH [ Time Frame: 7 days ]
  3. Decrease in reflux symptom index calculated by weekly regurgitation numbers [ Time Frame: 7 days ]
  4. Decrease in reflux symptom index calculated by weekly pyrosis numbers [ Time Frame: 7 days ]
  5. Percentage time of 24-hour intragastric pH >2 compared to baseline [ Time Frame: 7 days ]
  6. Percentage time of 24-hour intragastric pH >6 compared to baseline [ Time Frame: 7 days ]
  7. AUC of 24-hour intragastric pH >2 compared to baseline [ Time Frame: 7 days ]
  8. AUC of 24-hour intragastric pH >6 compared to baseline [ Time Frame: 7 days ]
  9. Percentage time of 24-hour total intragastric pH >4 compared to baseline [ Time Frame: 7 days ]
  10. AUC of 24-hour total intragastric pH >4 compared to baseline [ Time Frame: 7 days ]
  11. Percentage time of 24-hour total intragastric pH >4 between 11 pm and 7 am compared to baseline baseline [ Time Frame: 7 days ]
    rate of night reflux

  12. AUC of of 24-hour total intragastric pH >4 between 11 pm and 7 am compared to baseline [ Time Frame: 7 days ]
    rate of night reflux

  13. 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 ]
  14. Change in QT interval obtained by ECG compared to baseline [ Time Frame: 21 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT03037606


Locations
Layout table for location information
Turkey
Ege University Facult of Medicine Gastroenterology Department
Izmir, Turkey, 35100
Sponsors and Collaborators
Neutec Ar-Ge San ve Tic A.Ş

Layout table for additonal information
Responsible Party: Neutec Ar-Ge San ve Tic A.Ş
ClinicalTrials.gov Identifier: NCT03037606     History of Changes
Other Study ID Numbers: NEU-03.16
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action