NCT02761512

Brief Summary

To demonstrate non-inferiority of CJ-12420 to lansoprazole 30 mg capsule in terms of therapeutic efficacy, and to confirm safety of CJ-12420, after once daily oral administration of CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg capsule in gastric ulcer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
306

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2016

Typical duration for phase_3

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

May 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2018

Completed
Last Updated

August 22, 2019

Status Verified

April 1, 2018

Enrollment Period

2.2 years

First QC Date

May 1, 2016

Last Update Submit

August 20, 2019

Conditions

Gastric Ulcer

Outcome Measures

Primary Outcomes (1)

  • Cumulative healing rate of gastric ulcer at 8-week

    8 weeks

Secondary Outcomes (2)

  • Healing rate of gastric ulcer at 4-week

    4 weeks

  • Week 8 healing rates by H. pylori infection

    8 weeks

Study Arms (3)

CJ-12420 50 mg QD

EXPERIMENTAL

CJ-12420 50 mg, tablet, once daily, oral administration for up to 8 weeks

Drug: CJ-12420 50 mg QD

CJ-12420 100 mg QD

EXPERIMENTAL

CJ-12420 100 mg, tablet, once daily, oral administration for up to 8 weeks

Drug: CJ-12420 100 mg QD

Lansoprazole 30 mg QD

ACTIVE COMPARATOR

Lansoprazole 30 mg, capsule, once daily, oral administration for up to 8 weeks

Drug: Lansoprazole 30 mg QD

Interventions

CJ-12420 50 mg QDDRUG

CJ-12420 50 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of CJ-12420 50 mg.

Also known as: Not yet decided
CJ-12420 50 mg QD
CJ-12420 100 mg QDDRUG

CJ-12420 100 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of CJ-12420 100 mg.

Also known as: Not yet decided
CJ-12420 100 mg QD
Lansoprazole 30 mg QDDRUG

Lansoprazole 30 mg capsule will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of Lansoprazole 30 mg.

Also known as: Lanston cap.
Lansoprazole 30 mg QD

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Diagnosis of 1 or more active gastric ulcers (≥3 mm \~ ≤30 mm using open biopsy forceps) according to the Sakita-Miwa classification (A1 or A2 stage) from upper GI endoscopy at the same institution within 14 days prior to initiation of the investigational product administration.

You may not qualify if:

  • Finding of gastrointestinal bleeding, esophageal stricture, ulcer stenosis, pyloric stenosis, esophageal gastric varices, Barrett's esophageal of \>3 cm (long segment Barrett esophagus, LSBE), duodenal ulcer, intractable ulcer, digestive ulcer perforation or malignancy on upper GI endoscopy.
  • Ulcer caused by an endoscopic surgery (e.g., ulcer after EMR/ESD)
  • Requirement of persistent daily use of drugs that may cause an ulcer such as nonsteroidal anti-inflammatory drugs(NSAIDs) or aspirin during the course of the study
  • Scheduled surgery requiring hospitalization or requirement of surgical treatment during study participation
  • Subjects who participated in the other clinical trial within 4 weeks prior to randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Catholic Univ. Seoul St. Mary Hospita

Seoul, South Korea

Location

Kyung Hee University Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Ulcer

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Myung Gyu Choi, M.D., Ph.D

    Catholic Univ. Seoul St. Mary Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 1, 2016

First Posted

May 4, 2016

Study Start

May 1, 2016

Primary Completion

July 26, 2018

Study Completion

December 28, 2018

Last Updated

August 22, 2019

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)