- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02556021
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Non Erosive Reflux Disease
April 2, 2018 updated by: HK inno.N Corporation
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
324
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of
- Yeouido St.Mary's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CJ-12420 50mg
CJ-12420 50 mg, tablet, once daily, oral administration for up to 4 weeks
|
CJ-12420 50mg, tablet, once daily, oral administration for up to 4 weeks
Other Names:
|
Experimental: CJ-12420 100mg
CJ-12420 100 mg, tablet, once daily, oral administration for up to 4 weeks
|
CJ-12420 100mg, tablet, once daily, oral administration for up to 4 weeks
Other Names:
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Placebo Comparator: Placebo
Placebo, tablet, once daily, oral administration for up to 4 weeks
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Placebo, tablet, once daily, oral administration for up to 4 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
4 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resolution of main symptoms(heartburn and regurgitation) at 2-week(for 7 consecutive days)
Time Frame: 2 week
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2 week
|
|
RDQ score change
Time Frame: 4 week
|
4 week
|
|
Percentage of symptom free days
Time Frame: 4 week
|
Symptom will be collected by patient diary.
|
4 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 22, 2015
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
September 16, 2015
First Submitted That Met QC Criteria
September 21, 2015
First Posted (Estimate)
September 22, 2015
Study Record Updates
Last Update Posted (Actual)
April 4, 2018
Last Update Submitted That Met QC Criteria
April 2, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CJ_APA_302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-erosive Reflux Disease
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Daewoong Pharmaceutical Co. LTD.RecruitingNon-erosive Reflux Disease | Non-Erosive Gastro-Esophageal Reflux Disease | Non-Erosive Esophageal Reflux DiseaseKorea, Republic of
-
Braintree LaboratoriesEnrolling by invitationA Study to Evaluate the Long-Term Safety of BLI5100 in Patients With Gastroesophageal Reflux DiseaseNon-erosive Reflux Disease | Erosive EsophagitisUnited States
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Federal State Budgetary Scientific Institution...RecruitingGastroesophageal Reflux Disease | GERD | Non-erosive Reflux Disease | Erosive Esophagitis | Non-Erosive Gastro-Esophageal Reflux Disease | Gastroesophageal ErosionRussian Federation
-
Seoul National University Bundang HospitalCompletedErosive Reflux Disease | Non-erosive Reflux Disease | Functional HeartburnKorea, Republic of
-
TakedaTerminatedGastroesophageal Reflux Disease | Non-erosive Reflux DiseaseSwitzerland, Netherlands
-
Braintree LaboratoriesActive, not recruitingNon-erosive Reflux DiseaseUnited States
-
Midwest Biomedical Research FoundationKansas City Veteran Affairs Medical CenterCompletedNon-erosive Reflux DiseaseUnited States, United Kingdom
-
LCMC HealthTerminatedGastroesophageal Reflux | Non-erosive Reflux DiseaseUnited States
-
Yuhan CorporationCompletedNon-erosive Reflux DiseaseKorea, Republic of
-
Vanderbilt University Medical CenterCompletedGastroesophageal Reflux Disease (GERD) | Non-erosive Reflux Disease (NERD)United States
Clinical Trials on CJ-12420 50mg
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HK inno.N CorporationAsan Medical CenterCompleted
-
HK inno.N CorporationCompletedErosive EsophagitisKorea, Republic of
-
HK inno.N CorporationCompletedHealthyKorea, Republic of
-
HK inno.N CorporationCompleted
-
HK inno.N CorporationCompletedErosive EsophagitisKorea, Republic of
-
HK inno.N CorporationCompletedHealthyKorea, Republic of
-
HK inno.N CorporationCompletedGastric UlcerKorea, Republic of
-
HK inno.N CorporationCompletedTo Investigate PK and PD of CJ-12420, Clarithromycin, Amoxicillin After Multiple Dose AdministrationDrug Interaction | Pharmacokinetic | PharmacodynamicKorea, Republic of
-
HK inno.N CorporationCompletedGERD | Erosive EsophagitisKorea, Republic of
-
HK inno.N CorporationCompleted