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
  Purpose

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


Condition Intervention Phase
Erosive Esophagitis
GERD
Drug: Ilaprazole
Drug: Lansoprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Il-Yang Pharm. Co., Ltd.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Enrollment: 292
Study Start Date: July 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ilaprazole
Ilaprazole 20mg
Drug: Ilaprazole
20mg/Tap, QD
Other Name: Noltec
Active Comparator: lansoprazole
lansoprazole 30mg
Drug: Lansoprazole
30mg/Tap, QD

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509261

Locations
Korea, Republic of
Local Institution
Seoul, Korea, Republic of, 137-701
Local Institution
Seoul, Korea, Republic of, 150-713
Local Institution
Seoul, Korea, Republic of, 136-705
Local Institution
Seoul, Korea, Republic of, 152-703
Local Institution
Seoul, Korea, Republic of, 705-718
Local Institution
Seoul, Korea, Republic of, 626-770
Local Institution
Seoul, Korea, Republic of, 463-707
Local Institution
Seoul, Korea, Republic of, 135-710
Local Institution
Seoul, Korea, Republic of, 110-744
Local Institution
Seoul, Korea, Republic of, 140-743
Local Institution
Seoul, Korea, Republic of, 443-721
Local Institution
Seoul, Korea, Republic of, 120-752
Local Institution
Seoul, Korea, Republic of, 135-720
Local Institution
Seoul, Korea, Republic of, 614-735
Local Institution
Seoul, Korea, Republic of, 400-711
Local Institution
Seoul, Korea, Republic of, 501-757
Local Institution
Seoul, Korea, Republic of, 516-712
Local Institution
Seoul, Korea, Republic of, 301-721
Local Institution
Seoul, Korea, Republic of, 133-791
Sponsors and Collaborators
Il-Yang Pharm. Co., Ltd.
Investigators
Principal Investigator: Kim JinHo Asan Medical Center
  More Information

No publications provided

Responsible Party: Il-Yang Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT01509261     History of Changes
Other Study ID Numbers: IY-81149-EE03
Study First Received: January 10, 2012
Last Updated: January 10, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Il-Yang Pharm. Co., Ltd.:
Erosive Esophagitis
Ilaprazole
GERD

Additional relevant MeSH terms:
Esophagitis
Gastroesophageal Reflux
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Esophageal Motility Disorders
Deglutition Disorders
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014