Study to Confirm the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

NCT03006874 | Completed Phase 3

• 1 other identifier: CJ_APA_304
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to confirm the efficacy of CJ-12420, Once daily (QD), compared to esomeprazole in patients with erosive esophagitis classified as Los Angeles (LA) classification grades A to D at Week 8.

Conditions

Erosive Esophagitis

Outcome Measures

Primary Outcomes (1)

• Cumulative healing rate of erosive esophagitis at 8-week

  8 week

Secondary Outcomes (3)

• Healing rate of erosive esophagitis at 4-week

  4-week

• Symptom assessment by subject diary

  4-week or 8-week

• Symptom assessment by questionnaire

  4-week or 8-week

Study Arms (3)

CJ-12420 50mg QD

EXPERIMENTAL

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

Drug: CJ-12420 50mg QD

CJ-12420 100mg QD

EXPERIMENTAL

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

Drug: CJ-12420 100mg QD

Esomeprazole 40mg

ACTIVE COMPARATOR

Esomeprazole 40mg, tablet. once daily, oral administration for up to 8 weeks.

Drug: Esomeprazole 40mg

Interventions

CJ-12420 100mg QD DRUG

CJ-12420 100mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of CJ-12420 100mg.

Also known as: Tegoprazan Tab.

CJ-12420 100mg QD

Esomeprazole 40mg DRUG

Esomeprazole 40mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of Esomeprazole 40mg.

Also known as: Nexium Tab.

Esomeprazole 40mg

CJ-12420 50mg QD DRUG

CJ-12420 50mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of CJ-12420 50mg.

Also known as: Tegoprazan Tab.

CJ-12420 50mg QD

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged between 20 and 75 years
• Endoscopically confirmed erosive esophagitis as defined by LA Classification Grading System (A-D) within 14 days prior to randomization
• Subjects who had experienced heartburn and regurgitation within 7 days before visit 1
• Subjects who is able to understand and follow the instructions and is willing to participate throughout the entire study
• Subjects who voluntarily signed written informed consent form
• Subjects who agreed to use medically acceptable contraceptives during the period of study

You may not qualify if:

• Subjects who cannot undergo EGD
• Subjects who have esophageal stenosis, ulcer stenosis, gastroesophageal varices, Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by EGD
• Subjects who have warning symptoms of malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool
• Subjects with eosinophilic esophagitis
• Subjects diagnosed with primary esophageal motility disorder, IBS, IBD, etc. or with suspected IBS in the last 3 months
• Subjects who have a history of gastric acid suppression surgery or upper gastrointestinal, esophageal surgery
• Subjects who have AIDS or Hepatitis
• Subjects who take antipsychotic drugs, antidepressant drug, antianxiety drug
• Subjects who take gastric acid suppression like PPI within 2 weeks to EGD
• Subjects who take medications related to reflux esophagitis more than 2 times within 1 weeks to EGD
• 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
• Pregnant or lactating women
• Subjects with the following clinically significant laboratory abnormalities
• Subjects with the following clinically significant ECG abnormalities
• Sollinger-Ellison syndrome patients

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Interventions

tegoprazan; Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Poong Ryul Lee, Ph.D

  Samsung Medical Center

  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: June 14, 2016
• First Posted: December 30, 2016
• Study Start: May 2, 2016
• Primary Completion: March 24, 2017
• Study Completion: March 24, 2017
• Last Updated: September 12, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)