Efficacy Study of Ilaprazole to Treat Erosive Esophgitis

Phase 3

Completed

• Conditions: Erosive Esophagitis; GERD
• Interventions: Drug: Ilaprazole; Drug: Lansoprazole

• Registration Number: NCT01509261
• Lead Sponsor: Il-Yang Pharm. Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-01
• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-01-10
• Last Update Submitted: 2012-01-10
• Study First Posted: 2012-01-12
• Last Update Posted: 2012-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ilaprazole	Ilaprazole	Ilaprazole 20mg
lansoprazole	Lansoprazole	lansoprazole 30mg

Primary Outcome Measures

Name	Time	Method
The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy	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).

Secondary Outcome Measures

Name	Time	Method
The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy	4 Weeks

Trial Locations

Locations (1)

Local Institution; 🇰🇷 Seoul, Korea, Republic of