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Completed

NCT Number: NCT03006874

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

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.

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Key information

Conditions

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical Center

Seoul, 135-710, 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 three treatment groups (CJ-12420 50mg, CJ-12420 100mg, esomeprazole 40mg).

All subjects will be asked to take three 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 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

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
  • 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
  • Subjects with a history of malignant tumor
  • 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
  • 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
  • Subjects who are judged unsuitable to participate in the study in the opinion of the investigator

Treatment and study plan

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.

Other names: Tegoprazan Tab.

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.

Other names: Nexium Tab.

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.

Other names: Tegoprazan Tab.

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

    Time frame: 4-week or 8-week

  3. Symptom assessment by 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 Confirm the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 30, 2016
Registry last updated
Sep 12, 2017

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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