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

NCT03037606 | Completed Phase 4

• 1 other identifier: NEU-03.16
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• 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

Study Arms (2)

Rabelis DDR 50 mg Capsules and 1 placebo tablet

EXPERIMENTAL

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

Pariet 20 mg Enteric Coated Tablets and 1 placebo capsule

ACTIVE COMPARATOR

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

Interventions

Rabelis DDR 50 mg Capsules DRUG

Rabelis DDR 50 mg Capsules once daily for seven days.

Rabelis DDR 50 mg Capsules and 1 placebo tablet

Pariet 20 mg Enteric Coated Tablets DRUG

Pariet 20 mg Enteric Coated Tablets once daily for seven days.

Pariet 20 mg Enteric Coated Tablets and 1 placebo capsule

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neutec Ar-Ge San ve Tic A.Ş: lead

Study Sites (1)

Ege University Facult of Medicine Gastroenterology Department

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: January 31, 2017
• Study Start: August 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 11, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

TU (1)