Clinical trial NCT01509261: Efficacy Study of Ilaprazole to Treat Erosive Esophgitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erosive Esophagitis
GERD
Keywords: Erosive Esophagitis
Ilaprazole
GERD
Lead sponsor: Il-Yang Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-01-12
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy
timeFrame: 8 Weeks
Secondary outcomes:
measure: The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
Study officials:
affiliation: Asan Medical Center
name: Kim JinHo
role: PRINCIPAL_INVESTIGATOR
References: