An Efficacy Study to Compare the Treatment Effects of Rabeprazole and Lansoprazole Depending on the Genotyping of CYP2C19 in Treating Reflux Esophagitis

Overview

The purpose of this study is to compare the treatment effects of rabeprazole and lansoprazole depending on the genotyping (process of determining the genetic constitution) of CYP2C19 in treating reflux esophagitis (caused by gastroesophageal reflux; deterioration of the protective lining on the inner wall of the lower esophagus); and to evaluate the cure rate of reflux esophagitis on endoscopy (a thin flexible tube with a microscopic camera at the end which is passed down your throat into the esophagus, stomach, and duodenum) after treatment with rabeprazole and lansoprazole.

Full Title of Study: “Effect of Rabeprazole and Lansoprazole on Reflux Esophagitis in Relation to CYP2C19 Genotype Status: A Prospective, Randomized, Multicenter Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2008

Detailed Description

This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), multi-center (conducted in more than 1 center), randomized (study drug assigned by chance) study in participants with reflux esophagitis. The study will include 4 visits: Visit 1 (Screening period of up to 14 days), Visit 2 (Day 1), Visit 3 (Day 29+3), and Visit 4 (Day 56). After Screening, eligible participants will be analyzed on Visit 2 (Day 1) for symptoms during past week, At visit 3 (Day 29+3) participants will be randomly assigned to 1 of the 2 treatment groups: rabeprazole 20 milligram (mg) or lansoprazole 30 mg group. Participants will receive rabeprazole 20 mg tablet orally once daily for 28 to 56 days or lansoprazole 30 mg capsule orally once daily for 28 to 56 days. A post-study follow-up visit will be conducted only if participant will be affected by any serious adverse event within 30 days after the completion of study drug. Participants will primarily be assessed for the cure rate of reflux esophagitis based on endoscopy of 2 groups. Participants' safety will be monitored throughout the study.

Interventions

  • Drug: Rabeprazole
    • Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days.
  • Drug: Lansoprazole
    • Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days.

Arms, Groups and Cohorts

  • Experimental: Rabeprazole
    • Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days.
  • Active Comparator: Lansoprazole
    • Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19
    • Time Frame: Day 57
    • Reflux esophagitis evaluated by endoscopy as per LA Classification graded as: A=1 or more mucosal breaks no longer than 5 millimeter (mm) that did not extend between tops of 2 mucosal folds, B=1 or more mucosal breaks more than 5 mm long that did not extend between tops of 2 mucosal folds, C=1 or more mucosal break continuous between the tops of 2 or more mucosal folds but involves less than 75 percent of circumference, D=1 or more mucosal break involving at least 75 percent of circumference. Participants that were not categorized in any of the above mentioned grades (A to D) were considered as cured of reflux esophagitis. Participants were classified as CYP2C19 homozygous extensive, heterozygous extensive and poor metabolizers.

Secondary Measures

  • Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire
    • Time Frame: Baseline and Day 57
    • Gastroesophageal reflux disease and abdominal GI-related symptoms (heartburn, regurgitation, globus sensation, chronic cough, epigastric pain, non cardiac chest pain, hoarseness, dysphagia, abdominal distension, bloating, post-prandial discomfort, early satiety, nausea, vomiting, belching) experienced by participants were assessed and graded into 4 categories: 0 (Nothing)=No symptom, 1 (Mild)=A little but not uncomfortable, 2 (Moderate)=Present but interfering daily life activities a little, 3 (Severe)=Very uncomfortable, interfering daily life activities or sleeping.
  • Overall Assessment of Study Medication by Investigator
    • Time Frame: Day 57
    • Investigator’s overall assessment of study medication based on the global symptom assessment was measured. The assessment was categorized as: 2=very good, 1=good, 0=as usual, -1=bad and -2=very bad.

Participating in This Clinical Trial

Inclusion Criteria

  • Participants diagnosed with reflux esophagitis of Grade A or higher by Los Angeles (LA) classification based on the endoscopy among participants complaining of gastroesophageal reflux symptoms (such as: Heartburn, regurgitation, globus sensation, chronic [lasting a long time] cough [sudden, loud flow if air from the lungs], epigastric [area above the navel] pain, non-cardiac chest pain, hoarseness, or dysphagia), or those who diagnosed with reflux esophagitis of Grade B or higher without complaining of symptoms – Participants without other serious disease except the study indication (reflux esophagitis) – Participants with hematology (related to blood) panel, serum chemistry panel, or urinalysis result clinically within twice the normal range – Female Participants of child-bearing potential who are using the appropriate contraceptive or with a negative urine pregnancy test Exclusion Criteria:

  • Participants with other serious gastrointestinal disease except reflux esophagitis (example: digestive tract cancer [abnormal tissue that grows and spreads in the body until it kills], hepatic disease, pancreatic disease, and ulcer. However, the scar of an ulcer is included in study targets – Participants with other serious concomitant disease(s) such as renal disorder, cerebrovascular disease, cardiovascular disease, hepatic disease, and severe respiratory disease – Participants with medical history of upper gastrointestinal tract surgery, esophagostenosis, or a chalasia – Participants with hematology panel, serum chemistry panel, or urinalysis result of above twice the normal range – Participants who cannot discontinue proton pump inhibitors or Histamine 2 antagonist which may have influence on the study, 4 weeks before the start of this clinical study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Janssen Korea, Ltd., Korea
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Janssen Korea, Ltd., Korea Clinical Trial, Study Director, Janssen Korea, Ltd., Korea

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