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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Page 1 of 5 (19 locations)

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