Back to resultsStudy to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Non Erosive Reflux Disease
Primary Purpose
Non-erosive Reflux Disease
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CJ-12420 50mg
CJ-12420 100mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-erosive Reflux Disease
Eligibility Criteria
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
Sites / Locations
- Yeouido St.Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
CJ-12420 50mg
CJ-12420 100mg
Placebo
Arm Description
CJ-12420 50 mg, tablet, once daily, oral administration for up to 4 weeks
CJ-12420 100 mg, tablet, once daily, oral administration for up to 4 weeks
Placebo, tablet, once daily, oral administration for up to 4 weeks
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Resolution of main symptoms(heartburn and regurgitation) at 2-week(for 7 consecutive days)
RDQ score change
Percentage of symptom free days
Symptom will be collected by patient diary.
Full Information
NCT ID
NCT02556021
First Posted
September 16, 2015
Last Updated
April 2, 2018
Sponsor
HK inno.N Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02556021
Brief Title
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Non Erosive Reflux Disease
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 Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 22, 2015 (undefined)
Primary Completion Date
November 1, 2016 (Actual)
Study Completion Date
November 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HK inno.N Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-erosive Reflux Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
324 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CJ-12420 50mg
Arm Type
Experimental
Arm Description
CJ-12420 50 mg, tablet, once daily, oral administration for up to 4 weeks
Arm Title
CJ-12420 100mg
Arm Type
Experimental
Arm Description
CJ-12420 100 mg, tablet, once daily, oral administration for up to 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, tablet, once daily, oral administration for up to 4 weeks
Intervention Type
Drug
Intervention Name(s)
CJ-12420 50mg
Other Intervention Name(s)
Not yet decided
Intervention Description
CJ-12420 50mg, tablet, once daily, oral administration for up to 4 weeks
Intervention Type
Drug
Intervention Name(s)
CJ-12420 100mg
Other Intervention Name(s)
Not yet decided
Intervention Description
CJ-12420 100mg, tablet, once daily, oral administration for up to 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, tablet, once daily, oral administration for up to 4 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Resolution of main symptoms(heartburn and regurgitation) at 2-week(for 7 consecutive days)
Time Frame
2 week
Title
RDQ score change
Time Frame
4 week
Title
Percentage of symptom free days
Description
Symptom will be collected by patient diary.
Time Frame
4 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Yeouido St.Mary's Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34227708
Citation
Kim SH, Cho KB, Chun HJ, Lee SW, Kwon JG, Lee DH, Kim SG, Jung HY, Kim JW, Lee JS, Park H, Choi SC, Jee SR, Kim HS, Ko KH, Park SJ, Lee YC, Park SH, Kim AR, Kim EJ, Park HW, Kim BT, Song GS. Randomised clinical trial: comparison of tegoprazan and placebo in non-erosive reflux disease. Aliment Pharmacol Ther. 2021 Aug;54(4):402-411. doi: 10.1111/apt.16477. Epub 2021 Jul 6.
Results Reference
derived
Learn more about this trial
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Non Erosive Reflux Disease
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