Efficacy Study of Ilaprazole to Treat Erosive Esophgitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Erosive Esophagitis GERD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ilaprazole

Ilaprazole 20mg

Group Type EXPERIMENTAL

Ilaprazole

Intervention Type DRUG

20mg/Tap, QD

lansoprazole

lansoprazole 30mg

Group Type ACTIVE_COMPARATOR

Lansoprazole

Intervention Type DRUG

30mg/Tap, QD

Interventions

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Ilaprazole

20mg/Tap, QD

Intervention Type DRUG

Lansoprazole

30mg/Tap, QD

Intervention Type DRUG

Other Intervention Names

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Noltec

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No