NCT01509261

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
292

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
Last Updated

January 12, 2012

Status Verified

January 1, 2012

Enrollment Period

11 months

First QC Date

January 10, 2012

Last Update Submit

January 10, 2012

Conditions

Erosive EsophagitisGERD

Keywords

Erosive EsophagitisIlaprazoleGERD

Outcome Measures

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).

    8 Weeks

Secondary Outcomes (1)

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

    4 Weeks

Study Arms (2)

Ilaprazole

EXPERIMENTAL

Ilaprazole 20mg

Drug: Ilaprazole

lansoprazole

ACTIVE COMPARATOR

lansoprazole 30mg

Drug: Lansoprazole

Interventions

IlaprazoleDRUG

20mg/Tap, QD

Also known as: Noltec
Ilaprazole
LansoprazoleDRUG

30mg/Tap, QD

lansoprazole

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Local Institution

Seoul, 110-744, South Korea

Location

Local Institution

Seoul, 120-752, South Korea

Location

Local Institution

Seoul, 133-791, South Korea

Location

Local Institution

Seoul, 135-710, South Korea

Location

Local Institution

Seoul, 135-720, South Korea

Location

Local Institution

Seoul, 136-705, South Korea

Location

Local Institution

Seoul, 137-701, South Korea

Location

Local Institution

Seoul, 140-743, South Korea

Location

Local Institution

Seoul, 150-713, South Korea

Location

Local Institution

Seoul, 152-703, South Korea

Location

Local Institution

Seoul, 301-721, South Korea

Location

Local Institution

Seoul, 400-711, South Korea

Location

Local Institution

Seoul, 443-721, South Korea

Location

Local Institution

Seoul, 463-707, South Korea

Location

Local Institution

Seoul, 501-757, South Korea

Location

Local Institution

Seoul, 516-712, South Korea

Location

Local Institution

Seoul, 614-735, South Korea

Location

Local Institution

Seoul, 626-770, South Korea

Location

Local Institution

Seoul, 705-718, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

ilaprazoleLansoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Kim JinHo

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2012

First Posted

January 12, 2012

Study Start

July 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

January 12, 2012

Record last verified: 2012-01

Locations

KR(19)