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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Erosive Esophagitis GERD | Drug: Ilaprazole Drug: Lansoprazole | Phase 3 |
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 |
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
|
- 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).
- The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy [ Time Frame: 4 Weeks ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
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.

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
Korea, Republic of | |
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Seoul, Korea, Republic of, 110-744 | |
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Seoul, Korea, Republic of, 120-752 | |
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Seoul, Korea, Republic of, 133-791 | |
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Seoul, Korea, Republic of, 135-710 | |
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Seoul, Korea, Republic of, 135-720 | |
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Seoul, Korea, Republic of, 136-705 | |
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Seoul, Korea, Republic of, 137-701 | |
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Seoul, Korea, Republic of, 140-743 | |
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Seoul, Korea, Republic of, 150-713 | |
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Seoul, Korea, Republic of, 152-703 | |
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Seoul, Korea, Republic of, 301-721 | |
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Seoul, Korea, Republic of, 400-711 | |
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Seoul, Korea, Republic of, 443-721 | |
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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 |
Principal Investigator: | Kim JinHo | Asan Medical Center |
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 |