Status:
COMPLETED
Efficacy Study of Ilaprazole to Treat Erosive Esophgitis
Lead Sponsor:
Il-Yang Pharm. Co., Ltd.
Conditions:
Erosive Esophagitis
GERD
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study compared Ilaprazole 20mg with lansoprazole 30mg for the healing of erosive esophagitis and resolution of heartburn.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT01509261
Start Date
July 1 2010
End Date
June 1 2011
Last Update
January 12 2012
Active Locations (19)
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1
Local Institution
Seoul, South Korea, 110-744
2
Local Institution
Seoul, South Korea, 120-752
3
Local Institution
Seoul, South Korea, 133-791
4
Local Institution
Seoul, South Korea, 135-710