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Completed

NCT Number: NCT01509261

Efficacy Study of Ilaprazole to Treat Erosive Esophgitis

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

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Key information

Conditions

Erosive Esophagitis Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders GERD Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ilaprazole

Drug

20mg/Tap, QD

Other names: Noltec

Lansoprazole

Drug

30mg/Tap, QD

Primary outcomes

  1. The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy

    Time frame: 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 outcomes

  1. The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy

    Time frame: 4 Weeks

Sponsors and collaborators

Lead sponsor

Il-Yang Pharm. Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 12, 2012
Registry last updated
Jan 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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