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Completed

NCT Number: NCT02456935

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

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

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Key information

Conditions

Erosive Esophagitis

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

This is a double blind, randomized, active controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (CJ-12420 100 mg or esomeprazole 40 mg).

All subjects will be asked to take two tablets at the same time each day throughout the study, and also all subjects will be asked to record daytime and nighttime symptom in a subject diary on a daily basis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Not yet decided

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.

Other names: Nexium

Primary outcomes

  1. Cumulative healing rate of erosive esophagitis at 8-week

    Time frame: 8 week

Secondary outcomes

  1. Healing rate of erosive esophagitis at 4-week

    Time frame: 4 week

  2. Symptom assessment by subject diary and questionnaire

    Time frame: 4 week or 8 week

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

A Double-blind, Randomized, Active-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 29, 2015
Registry last updated
Dec 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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