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CompletedNCT01509261Updated Jan 12, 2012

Efficacy Study of Ilaprazole to Treat Erosive Esophgitis

A Phase 3 interventional study of Ilaprazole and Lansoprazole in Erosive Esophagitis and GERD, sponsored by Il-Yang Pharm. Co., Ltd.. Completed at 19 sites in Korea, Republic of. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-01-12.

Sponsored by Il-Yang Pharm. Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
292
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Erosive Esophagitis
  • GERD

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Keywords

  • Erosive Esophagitis
  • Ilaprazole
  • GERD
03

In context

Esophagitis

323 studies on the registry are indexed under Esophagitis; 38 are open to participants now.

This study's enrollment of 292 is above the median of 66 across 215 interventional studies indexed under Esophagitis.

Browse Esophagitis studies →

Lead sponsor

Il-Yang Pharm. Co., Ltd. is the lead sponsor of 31 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
292 participants (actual)

Study arms

  • Experimental
    Ilaprazole

    Ilaprazole 20mg

    Drug: Ilaprazole

  • Active comparator
    lansoprazole

    lansoprazole 30mg

    Drug: Lansoprazole

Interventions

  • DrugIlaprazole

    20mg/Tap, QD

    Also known as: Noltec

  • DrugLansoprazole

    30mg/Tap, QD

06

What researchers measure

Primary outcomes

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

    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).

    Time frame: 8 Weeks

Secondary outcomes

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

    Time frame: 4 Weeks

07

Study locations

19 sites
  • Local Institution
    Seoul, 110-744, Korea, Republic of
  • Local Institution
    Seoul, 120-752, Korea, Republic of
  • Local Institution
    Seoul, 133-791, Korea, Republic of
  • Local Institution
    Seoul, 135-710, Korea, Republic of
  • Local Institution
    Seoul, 135-720, Korea, Republic of
  • Local Institution
    Seoul, 136-705, Korea, Republic of
  • Local Institution
    Seoul, 137-701, Korea, Republic of
  • Local Institution
    Seoul, 140-743, Korea, Republic of
  • Local Institution
    Seoul, 150-713, Korea, Republic of
  • Local Institution
    Seoul, 152-703, Korea, Republic of
  • Local Institution
    Seoul, 301-721, Korea, Republic of
  • Local Institution
    Seoul, 400-711, Korea, Republic of
  • Local Institution
    Seoul, 443-721, Korea, Republic of
  • Local Institution
    Seoul, 463-707, Korea, Republic of
  • Local Institution
    Seoul, 501-757, Korea, Republic of
  • Local Institution
    Seoul, 516-712, Korea, Republic of
  • Local Institution
    Seoul, 614-735, Korea, Republic of
  • Local Institution
    Seoul, 626-770, Korea, Republic of
  • Local Institution
    Seoul, 705-718, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01509261
Lead sponsor
Il-Yang Pharm. Co., Ltd.
Responsible party
Sponsor
First posted
Jan 12, 2012
Start date
Jul 2010
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Jan 12, 2012

Study contacts

Kim JinHo
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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