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Efficacy Study of Ilaprazole to Treat Erosive Esophgitis

Primary Purpose

Erosive Esophagitis, GERD

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ilaprazole
Lansoprazole
Sponsored by
Il-Yang Pharm. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erosive Esophagitis focused on measuring Erosive Esophagitis, Ilaprazole, GERD

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Local Institution
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ilaprazole

lansoprazole

Arm Description

Ilaprazole 20mg

lansoprazole 30mg

Outcomes

Primary Outcome Measures

The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy
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).

Secondary Outcome Measures

The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy

Full Information

First Posted
January 10, 2012
Last Updated
January 10, 2012
Sponsor
Il-Yang Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01509261
Brief Title
Efficacy Study of Ilaprazole to Treat Erosive Esophgitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Il-Yang Pharm. Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Esophagitis, GERD
Keywords
Erosive Esophagitis, Ilaprazole, GERD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ilaprazole
Arm Type
Experimental
Arm Description
Ilaprazole 20mg
Arm Title
lansoprazole
Arm Type
Active Comparator
Arm Description
lansoprazole 30mg
Intervention Type
Drug
Intervention Name(s)
Ilaprazole
Other Intervention Name(s)
Noltec
Intervention Description
20mg/Tap, QD
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Intervention Description
30mg/Tap, QD
Primary Outcome Measure Information:
Title
The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy
Description
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).
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy
Time Frame
4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim JinHo
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
133-791
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
140-743
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
150-713
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
516-712
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
626-770
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
705-718
Country
Korea, Republic of

12. IPD Sharing Statement

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Efficacy Study of Ilaprazole to Treat Erosive Esophgitis

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