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

NCT02456935 | Completed Phase 3

• 1 other identifier: CJ_APA_301
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate 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 (2)

• Healing rate of erosive esophagitis at 4-week

  4 week

• Symptom assessment by subject diary and questionnaire

  4 week or 8 week

Study Arms (2)

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

Esomeprazole 40 mg QD

ACTIVE COMPARATOR

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

Drug: Esomeprazole 40 mg QD

Interventions

CJ-12420 100 mg QD DRUG

CJ-12420 100 mg 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 100 mg.

Also known as: Not yet decided

CJ-12420 100 mg QD

Esomeprazole 40 mg QD DRUG

Esomeprazole 40 mg 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 40 mg.

Also known as: Nexium

Esomeprazole 40 mg QD

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged between 20 and 70 years
• Subjects who had experienced heartburn and regurgitation within 7 days before visit 1. Entry into study also required that patients had experienced at least mild upper gastrointestinal symptoms on at least 2 days/week or at least moderate upper gastrointestinal symptoms on at least 1 day/week
• Endoscopically confirmed erosive esophagitis as defined by LA Classification Grading System (A-D) within 14 days prior to randomization
• 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
• Pregnant or lactating women
• Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine and CNS system disorder
• Subjects with a history of hypersensitivity to the active ingredient or excipients of the study drug, etc.
• Subjects who participated in the other clinical trial within 4 weeks prior to randomization

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

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

• Hyun Chae Jung, Ph.D

  Seoul National University 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 27, 2015
• First Posted: May 29, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

KR (1)