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

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Korea, Ltd., Korea
• Treatments: Dexlansoprazole; Lansoprazole; Rabeprazole

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