Efficacy Study of Ilaprazole to Treat Erosive Esophgitis

Il-Yang Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Erosive Esophagitis

GERD

Treatments

Drug: Lansoprazole

Drug: Ilaprazole

Study type

Interventional

Funder types

Industry

Identifiers

IY-81149-EE03

Details and patient eligibility

About

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

Enrollment

292 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.