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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01008696
Recruitment Status : Completed
First Posted : November 6, 2009
Results First Posted : August 13, 2013
Last Update Posted : August 13, 2013
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

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.

Condition or disease Intervention/treatment Phase
Reflux Esophagitis Drug: Rabeprazole Drug: Lansoprazole Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Rabeprazole and Lansoprazole on Reflux Esophagitis in Relation to CYP2C19 Genotype Status: A Prospective, Randomized, Multicenter Study
Study Start Date : May 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: Rabeprazole
Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days.
Drug: 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.
Drug: Lansoprazole
Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01008696

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
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Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
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Responsible Party: Janssen Korea, Ltd., Korea Identifier: NCT01008696    
Other Study ID Numbers: CR013831
First Posted: November 6, 2009    Key Record Dates
Results First Posted: August 13, 2013
Last Update Posted: August 13, 2013
Last Verified: July 2013
Keywords provided by Janssen Korea, Ltd., Korea:
Reflux esophagitis
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action