NCT01008696

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Reflux Esophagitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2009-11-06
• Last updated: 2013-08-13
• Results posted: 2013-08-13