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Efficacy Study of Ilaprazole to Treat Erosive Esophgitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Il-Yang Pharm. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01509261
First received: January 10, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted

January 10, 2012
January 10, 2012
July 2010
June 2011   (final data collection date for primary outcome measure)
The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
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).
Same as current
No Changes Posted
The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy Study of Ilaprazole to Treat Erosive Esophgitis
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

This study compared Ilaprazole 20mg with lansoprazole 30mg for the healing of erosive esophagitis and resolution of heartburn.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Erosive Esophagitis
  • GERD
  • Drug: Ilaprazole
    20mg/Tap, QD
    Other Name: Noltec
  • Drug: Lansoprazole
    30mg/Tap, QD
  • Experimental: Ilaprazole
    Ilaprazole 20mg
    Intervention: Drug: Ilaprazole
  • Active Comparator: lansoprazole
    lansoprazole 30mg
    Intervention: Drug: Lansoprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
292
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01509261
IY-81149-EE03
No
Il-Yang Pharm. Co., Ltd.
Il-Yang Pharm. Co., Ltd.
Not Provided
Principal Investigator: Kim JinHo Asan Medical Center
Il-Yang Pharm. Co., Ltd.
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP