A Phase 3 interventional study of JP-1366 simulation tablets and Esomeprazole Magnesium (Nexium) simulation tablets in Reflux Esophagitis (RE), sponsored by Livzon Pharmaceutical Group Inc.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-27.
Sponsored by Livzon Pharmaceutical Group Inc. (part of Joincare Pharmaceutical Group Industry Co., Ltd.) · Phase 3, Interventional, and Treatment
To evaluate the efficacy and safety of JP-1366 tablets and Nexium® (Esomeprazole magnesium enteric-coated tablets) in subjects with reflux esophagitis.
To evaluate the efficacy and safety of JP-1366 tablets and Nexium® (Esomeprazole magnesium enteric-coated tablets) in subjects with reflux esophagitis.
83 studies on the registry are indexed under Esophagitis, Peptic; 16 are open to participants now.
This study's planned enrollment of 356 is above the median of 135 across 60 interventional studies indexed under Esophagitis, Peptic.
Browse Esophagitis, Peptic studies →Livzon Pharmaceutical Group Inc. is the lead sponsor of 28 studies on the registry; 3 are open to participants now.
First submitted after Livzon Pharmaceutical Group Inc. became part of Joincare Pharmaceutical Group Industry Co., Ltd..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Those with a history of hemorrhagic stroke or any of the following intracranial diseases (bleeding, tumors, arteriovenous malformations (AVMs), or aneurysms); There are recurrent upper gastrointestinal or gastrointestinal ulcers/bleeding, and researchers believe that there is an increased risk of bleeding or clinical bleeding has occurred within the past 6 months before screening.
Those who have had acute clinical hepatitis or a history of major liver disease (active phase of chronic hepatitis, cirrhosis, or chronic liver dysfunction) within the past year before screening.
Screening for those who have had myocardial infarction, acute coronary syndrome, viral myocarditis, or pulmonary embolism within the past 6 months; those who have undergone coronary artery revascularization within 6 months; or ischemic stroke.
Patients with a history of chronic congestive heart failure and IV heart function.
There are severe arrhythmias that require treatment with Class Ia or III antiarrhythmic drugs; arrhythmias with diseased sinus syndrome, Class II or III atrioventricular block, and pacemakers have not yet been implanted.
People with a history of prolonged or screening period with QTc interval ≥ 480ms (according to Fridericia correction formula, where QTc = QT/RR \^ 0.33).
Subjects with any history of active malignant tumors within the first 5 years of screening (excluding cured basal cell carcinoma, papillary thyroid carcinoma, and radical resection of carcinoma in situ such as intraductal carcinoma of the and cervical carcinoma in situ).
Subjects who need to continue receiving non-steroidal anti-inflammatory drugs (such as aspirin), systemic , or antithrombotic drugs during the trial period (excluding those who use prophylactic low-dose aspirin (≤ 100mg/day)).
Total > 1.5 × ULN, (AST)/aspartate aminotransferase (ALT) > 3 × ULN.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
20 mg qd, last for 4-8 weeks
Drug: Esomeprazole Magnesium (Nexium) simulation tablets
40 mg qd, last for 4-8 weeks
Drug: JP-1366 simulation tablets
qd, last for 4-8 weeks
qd, last for 4-8 weeks
Percentage of subjects with esophageal mucosal healing confirmed by upper gastrointestinal endoscopy within 8 weeks of treatment
Time frame: Week 4-8
Percentage of subjects with esophageal mucosal healing confirmed by upper gastrointestinal endoscopy within 4 weeks of treatment
Time frame: Week 0-4
Changes in the severity of major symptoms (heartburn and reflux) compared to the base line at 4 and 8 weeks after treatment.
Time frame: Week 0-4 and week4-8
Changes in the frequency of major symptoms (heartburn and reflux) compared to the base line at 4 and 8 weeks after treatment.
Time frame: Week 0-4 and week4-8
Changes in the overall score of gastroesophageal reflux disease health-related quality of life (GERD-HRQL) compared to the base line at 4 and 8 weeks after treatment
evalutated by Gastroesophageal reflux disease health-related quality of life(GERD-HRQL), the value is \[-50,0\] and the lower score means better outcome.
Time frame: Week 0-4 and week4-8
The proportion of positive answers to "treatment satisfaction" in the GERD-HRQL scale
evalutated by Gastroesophageal reflux disease health-related quality of life(GERD-HRQL), it was measured by the proportion of postive answers of overall popultation
Time frame: Week 0-8
Changes in RDQ questionnaire scores compared to the base line at 4 and 8 weeks after treatment
evaluated by reflux disease questionnaire(RDQ), the value is \[-40,0\] and the lower scorce means better outcome.
Time frame: Week 0-4 and week4-8
Number of participants with treatment-related adverse events of Treatment and Control groups as assessed by CTCAE v4.0
Time frame: Week0-5 or Week 0-9
Percentage of subjects without major symptoms (heartburn and reflux) occurring within 1 week, 4 weeks, and 8 weeks after treatment (day, night, day, and night).
Time frame: Week0-4 or Week0-8
Percentage of days without major symptoms (heartburn and reflux) occurring within 1 week, 4 weeks, and 8 weeks after treatment (day, night, day, and night)
Time frame: Week0-4 or Week0-8
The first time there were no major symptoms (heartburn and reflux) for 7 consecutive days after treatment
Time frame: Week0-4 or Week0-8
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Studies of the drug tested here: Esomeprazole
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