NCT02638584

Brief Summary

This study compared Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and investigated Prevention of gastrointestinal bleeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P25-P50 for phase_4 gastric-cancer

Timeline
Completed

Started Dec 2015

Typical duration for phase_4 gastric-cancer

Geographic Reach
1 country

1 active site

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

December 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 23, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

July 31, 2020

Status Verified

August 1, 2018

Enrollment Period

2.2 years

First QC Date

December 14, 2015

Last Update Submit

July 29, 2020

Conditions

Gastric Cancer

Keywords

IlaprazoleGastric AdenomaEarly Gastric CancerEndoscopic Submucosal Dissection

Outcome Measures

Primary Outcomes (1)

  • The Ulcer healing rate after endoscopic submucosal dissection

    participants will be followed at 8 weeks

Secondary Outcomes (3)

  • The rate of Ulcer size reduction as assessed by measurements of ulcer size change.

    at 8 weeks after treatment

  • The quality of ulcer healing as evaluated by the observation of investigator at tracking endoscopy.

    at 8 weeks after treatment

  • The evaluation of symptom score as assessed by the Korean Gastrointestinal Symptom Rating Scale questionnaire.

    at 8 weeks after treatment

Study Arms (2)

Ilaprazole

EXPERIMENTAL

Ilaprazole tab 10mg, 2 tablets once daily for 8 weeks.

Drug: Ilaprazole

Rabeprazole

ACTIVE COMPARATOR

Rabeprazole tab 20mg, 1 tablet once daily for 8 weeks.

Drug: Rabeprazole

Interventions

IlaprazoleDRUG

Ilaprazole 10mg 2tablets once a day(1 times / day), before breakfast

Also known as: Ilaprazole(Noltec®)
Ilaprazole
RabeprazoleDRUG

Rabeprazole 20mg 1tablets once a day(1 times / day), before breakfast

Also known as: Pariet®
Rabeprazole

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year old ≤ Male or female \< 85 year old
  • Subject who underwent Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer
  • Subject who agrees to participate and spontaneously sign the Informed consent form(ICF).

You may not qualify if:

  • Known hypersensitivity to any component of ilaprazole
  • Subjects who are taking contraindicated medications(ex. atazanavir) for experimental and concomitant drug.
  • Subjects with abnormal levels in the laboratory tests
  • Total Bilirubin, Creatinine\> 1.5 times upper limit of normal
  • Alanine transaminase(ALT), Aspartate transaminase(AST), Alkaline phosphatase, Blood urea nitrogen(BUN)\> 2 times upper limit of normal
  • Subjects diagnosed with other cancer within 5 years other than stomach cancer.
  • Subjects with a history of Zollinger-Ellison syndrome, Barrett's esophagus, primary esophageal motility abnormality, esophageal strictures, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease
  • Subjects with a history of major surgery that can affect gastric acid secretion.
  • Subjects should continue taking the following medicine during the study period : anticholinergics, promoting motility agents, prostaglandin analogs, sucralfate, aspirin, steroid, NSAIDs drug
  • Subjects with uncontrolled organ failure (liver dysfunction, renal dysfunction)
  • Pregnant and/or lactating women
  • Subjects participating in a clinical trial before another trial within 30 days
  • Inconsistency judged subject by researcher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, South Korea

Location

Related Publications (1)

  • Bang CS, Shin WG, Seo SI, Choi MH, Jang HJ, Park SW, Kae SH, Yang YJ, Shin SP, Baik GH, Kim HY. Effect of ilaprazole on the healing of endoscopic submucosal dissection-induced gastric ulcer: randomized-controlled, multicenter study. Surg Endosc. 2019 May;33(5):1376-1385. doi: 10.1007/s00464-018-6412-9. Epub 2018 Aug 30.

    PMID: 30167954DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

ilaprazoleRabeprazole

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • ChangSeok Bang, MD, PhD

    HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2015

First Posted

December 23, 2015

Study Start

December 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

July 31, 2020

Record last verified: 2018-08

Locations

KR(1)