Efficacy Study of Ilaprazole to Treat Erosive Esophgitis
This study has been completed.
Sponsor:
Il-Yang Pharm. Co., Ltd.
Information provided by (Responsible Party):
Il-Yang Pharm. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01509261
First received: January 10, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
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Purpose
This study compared Ilaprazole 20mg with lansoprazole 30mg for the healing of erosive esophagitis and resolution of heartburn.
| Condition | Intervention | Phase |
|---|---|---|
|
Erosive Esophagitis GERD |
Drug: Ilaprazole Drug: Lansoprazole |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Il-Yang Pharm. Co., Ltd.:
Primary Outcome Measures:
- The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
| Enrollment: | 292 |
| Study Start Date: | July 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ilaprazole
Ilaprazole 20mg
|
Drug: Ilaprazole
20mg/Tap, QD
Other Name: Noltec
|
|
Active Comparator: lansoprazole
lansoprazole 30mg
|
Drug: Lansoprazole
30mg/Tap, QD
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509261
Locations
| Korea, Republic of | |
| Local Institution | |
| Seoul, Korea, Republic of, 137-701 | |
| Local Institution | |
| Seoul, Korea, Republic of, 150-713 | |
| Local Institution | |
| Seoul, Korea, Republic of, 136-705 | |
| Local Institution | |
| Seoul, Korea, Republic of, 152-703 | |
| Local Institution | |
| Seoul, Korea, Republic of, 705-718 | |
| Local Institution | |
| Seoul, Korea, Republic of, 626-770 | |
| Local Institution | |
| Seoul, Korea, Republic of, 463-707 | |
| Local Institution | |
| Seoul, Korea, Republic of, 135-710 | |
| Local Institution | |
| Seoul, Korea, Republic of, 110-744 | |
| Local Institution | |
| Seoul, Korea, Republic of, 140-743 | |
| Local Institution | |
| Seoul, Korea, Republic of, 443-721 | |
| Local Institution | |
| Seoul, Korea, Republic of, 120-752 | |
| Local Institution | |
| Seoul, Korea, Republic of, 135-720 | |
| Local Institution | |
| Seoul, Korea, Republic of, 614-735 | |
| Local Institution | |
| Seoul, Korea, Republic of, 400-711 | |
| Local Institution | |
| Seoul, Korea, Republic of, 501-757 | |
| Local Institution | |
| Seoul, Korea, Republic of, 516-712 | |
| Local Institution | |
| Seoul, Korea, Republic of, 301-721 | |
| Local Institution | |
| Seoul, Korea, Republic of, 133-791 | |
Sponsors and Collaborators
Il-Yang Pharm. Co., Ltd.
Investigators
| Principal Investigator: | Kim JinHo | Asan Medical Center |
More Information
No publications provided
| Responsible Party: | Il-Yang Pharm. Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01509261 History of Changes |
| Other Study ID Numbers: | IY-81149-EE03 |
| Study First Received: | January 10, 2012 |
| Last Updated: | January 10, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Il-Yang Pharm. Co., Ltd.:
|
Erosive Esophagitis Ilaprazole GERD |
Additional relevant MeSH terms:
|
Esophagitis Gastroesophageal Reflux Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis Esophageal Motility Disorders Deglutition Disorders |
Lansoprazole Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013