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

NCT01008696 | Completed Phase 4 Results

• 2 other identifiers: CR013831RAB-KOR-4023
• Study Type: interventional
• Target: 217
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Reflux Esophagitis

Keywords

Reflux esophagitis; Rabeprazole; Lansoprazole

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19

  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.

  Day 57

Secondary Outcomes (2)

• Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire

  Baseline and Day 57

• Overall Assessment of Study Medication by Investigator

  Day 57

Study Arms (2)

Rabeprazole

EXPERIMENTAL

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

Drug: Rabeprazole

Lansoprazole

ACTIVE COMPARATOR

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

Drug: Lansoprazole

Interventions

Rabeprazole DRUG

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

Rabeprazole

Lansoprazole DRUG

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

Lansoprazole

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Esophagitis, Peptic

Interventions

Rabeprazole; Lansoprazole

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Clinical Research Associate
• Organization: Medical Affairs, Seoul, Korea

82-2-2094-4835

Study Officials

• Janssen Korea, Ltd., Korea Clinical Trial

  Janssen Korea, Ltd., Korea

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 6, 2009
• Study Start: May 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 13, 2013
• Results First Posted: August 13, 2013

Record last verified: 2013-07