Effect of Rabeprazole and Lansoprazole on Reflux Esophagitis in Relation to CYP2C19 Genotype Status
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Purpose
This clinical study will compare the treatment effects of rabeprazole and lansoprazole depending on the genetic constitution of a enzyme in the liver in treating reflux esophagitis and the cure rate on endoscopy after treatment with rabeprazole 20 mg or lansoprazole 30 mg once daily for 4 to 8 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophagitis, Reflux |
Drug: rabeprazole; lansoprazole |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- Cure rate of reflux esophagitis will be observed on the gastric endoscopy (medical procedure that is used to assess the interior surfaces of an GI organ by inserting a tube into the body) [ Time Frame: At Baseline, Visit 3 (day 29 - plus or minus 3 days) or Visit 4 (day 57 - plus or minus 3 days) ] [ Designated as safety issue: No ]
- Improvement in symptoms of reflux esophagitis as measure by the symptom assessment questionnaire [ Time Frame: Visit 3 or Visit 4 ] [ Designated as safety issue: No ]
- Overall assessment of study medication by investigator [ Time Frame: Visit 3 or Visit 4 ] [ Designated as safety issue: No ]
| Enrollment: | 216 |
| Study Start Date: | May 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
This is prospective, randomized, comparative multicenter study. This clinical study will compare the treatment effects of rabeprazole and lansoprazole depending on the genotyping of CYP2C19 in treating reflux esophagitis and the cure rate on endoscopy after treatment with rabeprazole 20 mg or lansoprazole 30 mg once daily for 4 to 8 weeks. The primary objective of this clinical study is to evaluate the cure rate of reflux esophagitis as observed on the endoscopy of two groups. The secondary objective of this clinical study is to assess the symptom improvement of reflux esophagitis based on the patient symptom diary, symptom improvement according to the investigator, and the investigator's overall evaluation of the study drug. Patients without symptoms will be excluded from the analysis. Rabeprazole group: 20mg tablet once daily before meal for 28 - 56 days. Lansoprazole group: 30mg capsule once daily before breakfast for 28 - 56 days
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who agreed to participate in the study in writing fully understanding the explanation after listening to the clinical study process
- Those who were diagnosed with reflux esophagitis of Grade A or higher by Los Angeles (LA) classification based on the endoscopy among patients complaining of gastroesophageal reflux symptoms (one of the followings: Heartburn, Regurgitation, Globus sensation, Chronic cough, Epigastric pain, Non-cardiac chest pain, Hoarseness, or Dysphagia)
- Patients without other serious disease except the study indication
- Patients with hematology panel, serum chemistry panel, or urinalysis result clinically within twice the normal range
- Female patients of child-bearing potential who are using the appropriate contraceptive(s) (before participating in the clinical study, a urine pregnancy test should be negative)
Exclusion Criteria:
- Patients with other serious Gastrointestinal (GI) disease except reflux esophagitis (e.g., digestive tract cancer, hepatic disease, pancreatic disease, and active ulcer
- Patients with other serious concomitant disease(s) such as renal disorder, cerebrovascular disease, cardiovascular disease, hepatic disease, and severe respiratory disease
- Patients with medical history of upper gastrointestinal tract surgery, esophagostenosis, or achalasia
- Patients with hematology panel, serum chemistry panel, or urinalysis result of above twice the normal range
- Patients who cannot discontinue a Proton Pump Inhibitor (PPI) or Histamine receptor (H2) antagonist which may have influence on the study, 4 weeks prior to the start of this clinical study
- Females in pregnancy or nursing
Contacts and Locations More Information
No publications provided
| Responsible Party: | Clinical Research Director, Janssen Korea, Ltd., Korea |
| ClinicalTrials.gov Identifier: | NCT01008696 History of Changes |
| Other Study ID Numbers: | CR013831 |
| Study First Received: | November 5, 2009 |
| Last Updated: | April 26, 2010 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Janssen Korea, Ltd., Korea:
|
Rabeprazole Lansoprazole Genotype Proton-pump inhibitor |
Additional relevant MeSH terms:
|
Esophagitis Esophagitis, Peptic Gastroesophageal Reflux Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis Peptic Ulcer Esophageal Motility Disorders Deglutition Disorders |
Lansoprazole Rabeprazole Proton Pump Inhibitors Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013