Efficacy Study of Ilaprazole to Treat Erosive Esophgitis

January 10, 2012 updated by: Il-Yang Pharm. Co., Ltd.

A Phase Ⅲ Multi-center, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Ilaprazole (20mg QD) in Adult Patients With Erosive Esophagitis

This study compared Ilaprazole 20mg with lansoprazole 30mg for the healing of erosive esophagitis and resolution of heartburn.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

292

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Local Institution
      • Seoul, Korea, Republic of, 120-752
        • Local Institution
      • Seoul, Korea, Republic of, 135-710
        • Local Institution
      • Seoul, Korea, Republic of, 135-720
        • Local Institution
      • Seoul, Korea, Republic of, 136-705
        • Local Institution
      • Seoul, Korea, Republic of, 137-701
        • Local Institution
      • Seoul, Korea, Republic of, 133-791
        • Local Institution
      • Seoul, Korea, Republic of, 140-743
        • Local Institution
      • Seoul, Korea, Republic of, 150-713
        • Local Institution
      • Seoul, Korea, Republic of, 152-703
        • Local Institution
      • Seoul, Korea, Republic of, 301-721
        • Local Institution
      • Seoul, Korea, Republic of, 400-711
        • Local Institution
      • Seoul, Korea, Republic of, 443-721
        • Local Institution
      • Seoul, Korea, Republic of, 463-707
        • Local Institution
      • Seoul, Korea, Republic of, 501-757
        • Local Institution
      • Seoul, Korea, Republic of, 516-712
        • Local Institution
      • Seoul, Korea, Republic of, 614-735
        • Local Institution
      • Seoul, Korea, Republic of, 626-770
        • Local Institution
      • Seoul, Korea, Republic of, 705-718
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D) within 14 days prior to baseline.
  • Episodes of heartburn or regurgitation has experienced during the last 7 days prior to baseline.

Exclusion Criteria:

  • Coexisting diseases affecting the esophagus (eg, eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, or esophageal stricture), history of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus. Presence of a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter) or Barrett's esophagus were not exclusionary.
  • Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.
  • Known hypersensitivity to any PPI (including lansoprazole, omeprazole, rabeprazole, pantoprazole or esomeprazole), any component of ilaprazole, or Gelusil.
  • Cancer (except basal cell carcinoma of the skin) within 5 years prior to screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ilaprazole
Ilaprazole 20mg
Drug: Ilaprazole
20mg/Tap, QD
Other Names:
  • Noltec
Active Comparator: lansoprazole
lansoprazole 30mg
Drug: Lansoprazole
30mg/Tap, QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy
Time Frame: 8 Weeks
Endoscopic healing of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break <5 mm), Grade B (Mucosal break ≥5 mm), Grade C (Mucosal break continuous between two or more folds and <75% of the circumference) and Grade D (Mucosal break ≥75% of the circumference).
8 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy
Time Frame: 4 Weeks
4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Il-Yang Pharm. Co., Ltd.

Investigators

  • Principal Investigator: Kim JinHo, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

January 10, 2012

First Submitted That Met QC Criteria

January 10, 2012

First Posted (Estimate)

January 12, 2012

Study Record Updates

Last Update Posted (Estimate)

January 12, 2012

Last Update Submitted That Met QC Criteria

January 10, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IY-81149-EE03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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