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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02556021
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Non-erosive Reflux Disease Drug: CJ-12420 50mg Drug: CJ-12420 100mg Drug: Placebo Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : September 22, 2015
Actual Primary Completion Date : November 1, 2016
Actual Study Completion Date : November 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: CJ-12420 50mg
CJ-12420 50 mg, tablet, once daily, oral administration for up to 4 weeks
Drug: CJ-12420 50mg
CJ-12420 50mg, tablet, once daily, oral administration for up to 4 weeks
Other Name: Not yet decided

Experimental: CJ-12420 100mg
CJ-12420 100 mg, tablet, once daily, oral administration for up to 4 weeks
Drug: CJ-12420 100mg
CJ-12420 100mg, tablet, once daily, oral administration for up to 4 weeks
Other Name: Not yet decided

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects aged between 20 and 75 years
  2. Subjects who had experienced a minimum three-month history of main symptom(heartburn and regurgitation)
  3. Subjects were to have normal esophagus confirmed by endoscopy within 14 days prior to randomization
  4. Subjects who is able to understand and follow the instructions and is willing to participate throughout the entire study
  5. Subjects who voluntarily signed written informed consent form
  6. Subjects who agreed to use medically acceptable contraceptives during the period of study
  7. 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:

  1. Subjects who cannot undergo EGD
  2. Subjects who have esophageal stenosis, ulcer stenosis, gastroesophageal varices, Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by EGD
  3. 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.
  4. Subjects who have warning symptoms of malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool
  5. Subjects with eosinophilic esophagitis
  6. Subjects diagnosed with functional dyspepsia, primary esophageal motility disorder, IBS, IBD, etc. or with suspected IBS in the last 3 months
  7. Subjects who have a history of gastric acid suppression surgery or upper gastrointestinal, esophageal surgery
  8. Subjects who have bipolar disorder, anxiety disorder, panic disorder, somatoform disorder, personality disorder and psychiatric disorders.
  9. Subjects who are taking antipsychotic drugs, antidepressants or antianxiety medications
  10. Subjects who should continuously administer NSAIDs during the trial.
  11. Pregnant or lactating women
  12. Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine and CNS system disorder
  13. Subjects with a history of hypersensitivity to the active ingredient or excipients of the study drug, etc.
  14. Subjects who participated in the other clinical trial within 4 weeks prior to randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556021


Locations
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Korea, Republic of
Yeouido St.Mary's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
CJ HealthCare Corporation
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Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT02556021    
Other Study ID Numbers: CJ_APA_302
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases