- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05443984
JP-1366 20mg Versus Esomeprazole 40mg in Patients With Erosive Esophagitis
A Randomized, Double-blind, Parallel, Active-controlled, Non-inferiority, Phase III Multiple Center Clinical Trial to Compare the Efficacy and Safety of JP-1366 20 mg Versus Esomeprazole 40 mg in Patients With Erosive Esophagitis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Asan Medical Center and 26 hospitals
-
Contact:
- Jung HoonYong, Prof
- Phone Number: 02-3454-0780
- Email: onconictherapeutics@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Subjects must satisfy all the following criteria.
- Male or female, ≥ 19 years of age at the time of obtaining consent
Subjects who had experienced heartburn and regurgitation within 7 days prior to the screening visit, those whose severity and frequency of symptoms fall under the following (1) or (2)
⑴ Subjects who have experienced mild or more severe heartburn or regurgitation at least twice a week
⑵ Subjects who have experienced moderate or more severe heartburn or regurgitation at least once a week
- Endoscopically confirmed grade A or higher erosive esophagitis as defined by †LosAngeles classification within 15 days, prior to randomization
- Subjects who fully understand this study and voluntarily signed on the informed consent form
Exclusion Criteria: Subjects may not satisfy any of the following criteria.
- Subjects who can't undergo endoscopy
Medical History
º Subjects who have warning symptoms of the malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool. (except negative result for malignancy by endoscopy)
º Subjects with eosinophilic esophagitis (except negative result by esophageal biopsy)
º Subjects who have esophageal stenosis, gastroesophageal varices, Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding, or malignant tumor confirmed by EGD
º Zollinger-Ellison syndrome patients
º Subjects diagnosed with primary esophageal motility disorder, irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or suspected with IBS in the last 3 months and with a current history of the disease including pancreatitis
º Subjects who have a history of gastric acid suppression surgery, gastrointestinal or esophageal surgery (except appendectomy, cholecystectomy, polypectomy)
º Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine, urinary, neuro-psychiatric, hemato-oncologic disorder
º Subjects who have a history of malignant tumor in 5 years at the time of screening. However, excluding subjects with malignant gastrointestinal cancer regardless of the period.
Laboratory Test
Screening laboratory test showing any of the following abnormal laboratory results:
º ALT or AST > 2.0 x ULN
º ALP or GGT > 2.0 x ULN
º Total bilirubin > 2.0 x ULN
º eGFR<70 mL/min/1.73 m2 (CKD-EPI formula)
º Positive result for Serological test (HBsAg, HCV Ab, HIV Ab, Syphilis reagin test)
º Clinically significant ECG abnormalities
Allergy and drug hypersensitivity
º Known hypersensitivity to the active ingredient or excipients of the investigational product
º Clinically significant allergies (except mild allergic rhinitis) or hypersensitivity history to drugs. (Aspirin, antibiotics, etc.)
Prohibited medication and therapy
º Subjects who take gastric acid suppressant like P-CAB, PPI within 2weeks prior to EGD of screening procedure
º Subjects who take medication (antacids, prokinetics, H2RA, etc.) related to reflux esophagitis more than 2times within 1week prior to EGD of screening procedure
º Subjects who need to take medication (aspirin, NSAIDs, etc.) that may cause an ulcer, during the study period
º Subjects who are on or need to be on the medications which categorized as contraindicated in this clinical trial.
However, subjects who are on the contraindicated medications can participate in the trial after the washout period of 2 weeks. If five times of the half-life of the contraindicated medications exceeds 2 weeks, the washout period will be set as five times of the half-life.
- Pregnant and lactating women
- Contraception Subjects who do not agree to use medically acceptable methods of contraception during the period study
- Subjects with clinically significant psychiatric disorder and a history with a drug and alcohol abuse.
- Subjects who are judged unsuitable to participate in the study in the opinion of the investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
JP-1366 20mg + Esomeprazole 40mg(placebo)
|
1 capsule of JP-1366 20 mg, 1 tablet of esomeprazole placebo (irrespective of meals)
|
Active Comparator: Active Comparative Group
JP-1366 20mg(placebo) + Esomeprazole 40mg
|
1 capsule of JP-1366 placebo, 1 tablet of esomeprazole 40 mg placebo (irrespective of meals)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The cumulative healing rate of mucosal break at 8-week after the investigational product administration (%)
Time Frame: Week 8
|
The proportion of subjects with remission on EGD at 8-week
|
Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healing rate of mucosal break at the 4-week after the investigational product administration
Time Frame: Week 4
|
Ratio of subjects whose mucosal breaks are healed on the 4th week endoscopy
|
Week 4
|
Healing rate of mucosal break evaluated by an independent evaluator at the 4-week after the investigational product administration and cumulative healing rate of mucosal break at 8 weeks
Time Frame: Week 4
|
Week 4
|
|
Healing rate of mucosal break evaluated by an independent evaluator at the 8-week after the investigational product administration
Time Frame: Week 8
|
Ratio of subjects whose mucosal breaks are healed on the 8-week endoscopy evaluated by an independent evaluator.
|
Week 8
|
Symptom assessment according to the RDQ questionnaire
Time Frame: Week 4 and 8
|
Week 4 and 8
|
|
Gastro-esophageal symptoms at 4, 8 weeks after investigational product administration compared to baseline) and cumulative gastroesophageal symptoms at 8 weeks
Time Frame: within 24hours after IP administration, during 7days after IP administration, Week 4 and 8
|
Amount of change in the score of the intensity and frequency of the main symptoms according to the RDQ questionnaire Symptom assessment according to the subject diary
|
within 24hours after IP administration, during 7days after IP administration, Week 4 and 8
|
Change from baseline in the total score of GERD-HRQL at 4, 8-week and cumulative changes in quality of life at 8week
Time Frame: Week 4 and 8
|
The proportion of positive responder to 'treatment satisfaction' according to the GERD-Health Related Quality of Life (GERD-HRQL)
|
Week 4 and 8
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exploratory variables
Time Frame: Week 4 and 8
|
Cumulative healing rate according to H.pylori infection: Percentage of subjects whose mucosal break were healed on EGD at 4 and 8 weeks after IP administration
|
Week 4 and 8
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JP-1366-301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Erosive Esophagitis
-
AstraZenecaLaboratory Corporation of America; Medidata Solutions; IQVIA RDS Inc.; Calyx; Thermo... and other collaboratorsRecruitingErosive EsophagitisUnited States, Italy, Belgium, Vietnam, Spain, Portugal, Russian Federation, Argentina, Greece, Australia, Lithuania
-
Konkuk University Medical CenterDaewoong Pharmaceutical Co. LTD.RecruitingErosive EsophagitisKorea, Republic of
-
Cinclus Pharma AGParexelCompletedErosive EsophagitisPoland, Bulgaria, Serbia, Georgia, United States, Czechia, Hungary, Ukraine
-
Boryung Pharmaceutical Co., LtdCompleted
-
HK inno.N CorporationCompletedErosive EsophagitisKorea, Republic of
-
HK inno.N CorporationCompletedErosive EsophagitisKorea, Republic of
-
TakedaCompletedErosive EsophagitisJapan
-
Braintree LaboratoriesRecruitingErosive EsophagitisUnited States
-
Phathom Pharmaceuticals, Inc.CompletedErosive EsophagitisUnited States, Poland, Bulgaria, United Kingdom, Czechia, Hungary
-
Daewoong Pharmaceutical Co. LTD.Hanyang UniversityUnknownErosive EsophagitisKorea, Republic of
Clinical Trials on JP-1366 20mg
-
Onconic Therapeutics Inc.CompletedHealthyKorea, Republic of
-
Onconic Therapeutics Inc.Not yet recruiting
-
Jeil Pharmaceutical Co., Ltd.Completed
-
Onconic Therapeutics Inc.Completed
-
Onconic Therapeutics Inc.Not yet recruiting
-
Onconic Therapeutics Inc.CompletedAnti-Ulcer AgentsKorea, Republic of
-
Onconic Therapeutics Inc.CompletedHelicobacter Pylori Associated Gastrointestinal DiseaseKorea, Republic of
-
Jeil Pharmaceutical Co., Ltd.Recruiting
-
Juvantia Pharma LtdSanthera PharmaceuticalsCompletedParkinson's DiseaseUnited States, India
-
Norwegian University of Science and TechnologyInstituto Mexicano del Seguro Social; Picterus ASRecruiting