Skip to main content
OpenTrials
Completed

NCT Number: NCT02556021

Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Non Erosive Reflux Disease

The purpose of this study is to demonstrate the superiority of efficacy of CJ-12420, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yeouido St.Mary's Hospital

Seoul, South Korea

About this study

This is a double blind, randomized, placebo-controlled, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (CJ-12420 50 mg or 100 mg or placebo).

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 daily 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
  • Subjects who had experienced a minimum three-month history of main symptom(heartburn and regurgitation)
  • Subjects were to have normal esophagus confirmed by endoscopy 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
  • Subjects who had experienced heartburn and regurgitation within 7 days before randomization. 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

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 erosive esophagitis, acute upper gastrointestinal bleeding, gastric ulcers or duodenal ulcers, acute erosive gastritis within 2 months before randomization. Subjects with gastric or duodenal erosions are allowed to be included.
  • 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 functional dyspepsia, 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 bipolar disorder, anxiety disorder, panic disorder, somatoform disorder, personality disorder and psychiatric disorders.
  • Subjects who are taking antipsychotic drugs, antidepressants or antianxiety medications
  • Subjects who should continuously administer NSAIDs during the trial.
  • 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 50mg

Drug

CJ-12420 50mg, tablet, once daily, oral administration for up to 4 weeks

Other names: Not yet decided

CJ-12420 100mg

Drug

CJ-12420 100mg, tablet, once daily, oral administration for up to 4 weeks

Other names: Not yet decided

Placebo

Drug

Placebo, tablet, once daily, oral administration for up to 4 weeks

Primary outcomes

  1. Percentage of patients with complete resolution of main symptoms (heartburn and regurgitation) at 4-week, defined as no episodes of symptom during the last 7 days of treatment, using Reflux Disease Questionnaire(RDQ)

    Time frame: 4 week

Secondary outcomes

  1. Resolution of main symptoms(heartburn and regurgitation) at 2-week(for 7 consecutive days)

    Time frame: 2 week

  2. RDQ score change

    Time frame: 4 week

  3. Percentage of symptom free days

    Time frame: 4 week

    Symptom will be collected by patient diary.

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of CJ-12420 in Patients With Non-erosive Reflux Disease

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 22, 2015
Registry last updated
Apr 4, 2018

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.

Published trials that share one or more normalized conditions with this study.