An Efficacy Study to Compare the Treatment Effects of Rabeprazole and Lansoprazole Depending on the Genotyping of CYP2C19 in Treating Reflux Esophagitis
Condition: Reflux Esophagitis
MeSH terms: Gastroesophageal Reflux; Esophagitis; Esophagitis, Peptic
Intervention: Rabeprazole; Lansoprazole
Intervention description: Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days.; Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days.
Intervention MeSH terms: Rabeprazole; Lansoprazole; Dexlansoprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Reflux esophagitis; Rabeprazole; Lansoprazole

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.
    

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