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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037606
• Other study ID #: NEU-03.16
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2017
• Est. completion date: December 11, 2018

Study information

• Verified date: December 2018
• Source: Neutec Ar-Ge San ve Tic A.S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 11, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Rabelis DDR 50 mg Capsules
Rabelis DDR 50 mg Capsules once daily for seven days.
• Pariet 20 mg Enteric Coated Tablets
Pariet 20 mg Enteric Coated Tablets once daily for seven days.

Locations

Country	Name	City	State
Turkey	Ege University Facult of Medicine Gastroenterology Department	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Neutec Ar-Ge San ve Tic A.S

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage time of 24-hour intragastric pH >4 compared to baseline		7 days
Primary	AUC of 24-hour intragastric pH >4 compared to baseline		7 days
Secondary	Significant increase in total measurements of median pH		7 days
Secondary	Significant increase in nocturnal measurements of median pH		7 days
Secondary	Decrease in reflux symptom index calculated by weekly regurgitation numbers		7 days
Secondary	Decrease in reflux symptom index calculated by weekly pyrosis numbers		7 days
Secondary	Percentage time of 24-hour intragastric pH >2 compared to baseline		7 days
Secondary	Percentage time of 24-hour intragastric pH >6 compared to baseline		7 days
Secondary	AUC of 24-hour intragastric pH >2 compared to baseline		7 days
Secondary	AUC of 24-hour intragastric pH >6 compared to baseline		7 days
Secondary	Percentage time of 24-hour total intragastric pH >4 compared to baseline		7 days
Secondary	AUC of 24-hour total intragastric pH >4 compared to baseline		7 days
Secondary	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
Secondary	AUC of of 24-hour total intragastric pH >4 between 11 pm and 7 am compared to baseline	rate of night reflux	7 days
Secondary	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
Secondary	Change in QT interval obtained by ECG compared to baseline		21 days