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

NCT ID: NCT01008696

Last Updated: 2013-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-08-31

Brief 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

Keywords

Reflux esophagitis; Rabeprazole; Lansoprazole

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rabeprazole

Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days.

Group Type: EXPERIMENTAL

Rabeprazole

Intervention Type: DRUG

Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days.

Lansoprazole

Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days.

Group Type: ACTIVE_COMPARATOR

Lansoprazole

Intervention Type: DRUG

Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days.

Interventions

Rabeprazole

Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days.

Intervention Type: DRUG

Lansoprazole

Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Korea, Ltd., Korea Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd., Korea

Other Identifiers

RAB-KOR-4023

Identifier Type: -

Identifier Source: secondary_id

CR013831

Identifier Type: -

Identifier Source: org_study_id