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Efficacy Study of Ilaprazole to Treat Erosive Esophgitis

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ClinicalTrials.gov Identifier: NCT01509261
Recruitment Status : Completed
First Posted : January 12, 2012
Last Update Posted : January 12, 2012
Sponsor:
Information provided by (Responsible Party):
Il-Yang Pharm. Co., Ltd.

Study Description
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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
Erosive Esophagitis GERD Drug: Ilaprazole Drug: Lansoprazole Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : July 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Ilaprazole
Ilaprazole 20mg
 Drug: Ilaprazole
20mg/Tap, QD
Other Name: Noltec
Active Comparator: lansoprazole
lansoprazole 30mg
 Drug: Lansoprazole
30mg/Tap, QD


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy [ Time Frame: 4 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509261


Locations
Korea, Republic of
Local Institution
Seoul, Korea, Republic of, 110-744
Local Institution
Seoul, Korea, Republic of, 120-752
Local Institution
Seoul, Korea, Republic of, 133-791
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, 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
Sponsors and Collaborators
Il-Yang Pharm. Co., Ltd.
Investigators
Principal Investigator: Kim JinHo Asan Medical Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Il-Yang Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT01509261     History of Changes
Other Study ID Numbers: IY-81149-EE03
First Posted: January 12, 2012    Key Record Dates
Last Update Posted: January 12, 2012
Last Verified: January 2012

Keywords provided by Il-Yang Pharm. Co., Ltd.:
Erosive Esophagitis
Ilaprazole
GERD

Additional relevant MeSH terms:
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Lansoprazole
 Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action