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Efficacy Study of Ilaprazole to Treat Erosive Esophgitis

Sponsor
Il-Yang Pharm. Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01509261
Collaborator
(none)
292
Enrollment
19
Locations
2
Arms
11
Duration (Months)
15.4
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
292 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Jul 1, 2010
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy [4 Weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Seoul Korea, Republic of 110-744
    2 Local Institution Seoul Korea, Republic of 120-752
    3 Local Institution Seoul Korea, Republic of 133-791
    4 Local Institution Seoul Korea, Republic of 135-710
    5 Local Institution Seoul Korea, Republic of 135-720
    6 Local Institution Seoul Korea, Republic of 136-705
    7 Local Institution Seoul Korea, Republic of 137-701
    8 Local Institution Seoul Korea, Republic of 140-743
    9 Local Institution Seoul Korea, Republic of 150-713
    10 Local Institution Seoul Korea, Republic of 152-703
    11 Local Institution Seoul Korea, Republic of 301-721
    12 Local Institution Seoul Korea, Republic of 400-711
    13 Local Institution Seoul Korea, Republic of 443-721
    14 Local Institution Seoul Korea, Republic of 463-707
    15 Local Institution Seoul Korea, Republic of 501-757
    16 Local Institution Seoul Korea, Republic of 516-712
    17 Local Institution Seoul Korea, Republic of 614-735
    18 Local Institution Seoul Korea, Republic of 626-770
    19 Local Institution Seoul Korea, Republic of 705-718

    Sponsors and Collaborators

    • Il-Yang Pharm. Co., Ltd.

    Investigators

    • Principal Investigator: Kim JinHo, Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Il-Yang Pharm. Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01509261
    Other Study ID Numbers:
    • IY-81149-EE03
    First Posted:
    Jan 12, 2012
    Last Update Posted:
    Jan 12, 2012
    Last Verified:
    Jan 1, 2012
    Keywords provided by Il-Yang Pharm. Co., Ltd.
    Erosive Esophagitis
    Ilaprazole
    GERD
    Additional relevant MeSH terms:
    Esophagitis
    Lansoprazole
    Dexlansoprazole

    Study Results

    No Results Posted as of Jan 12, 2012