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RecruitingNCT06850480Updated Feb 27, 2025

A Phase III Clinical Trial for Efficacy and Safety Evaluation of JP-1366 Tablets on Reflux Esophagitis

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

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Dec 2024; still recruiting 1 year 11 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
356
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To evaluate the efficacy and safety of JP-1366 tablets and Nexium® (Esomeprazole magnesium enteric-coated tablets) in subjects with reflux esophagitis.

Read the detailed description

To evaluate the efficacy and safety of JP-1366 tablets and Nexium® (Esomeprazole magnesium enteric-coated tablets) in subjects with reflux esophagitis.

02

Conditions studied

  • Reflux Esophagitis (RE)

Browse trials for

03

In context

Esophagitis, Peptic

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Voluntarily participate and sign a written form, and be able to understand the information provided and comply with the program requirements;
  2. Age between 18-75 years old (including boundary values) during screening, both male and female are acceptable.
  3. Those who have experienced heartburn and reflux symptoms (with medical records) within 7 days before screening or who have been diagnosed with reflux esophagitis by endoscopic examination within 7 days before screening;
  4. Screening period for upper gastrointestinal endoscopy, diagnosed with grade A-D reflux esophagitis in Los Angeles (those who have received endoscopic examination results from our center, have been judged by researchers to meet the diagnostic criteria, and have not been examined within 14 days before randomization, do not need to repeat this examination).
  5. LA-A level subjects, esophageal reflux monitoring during the screening period, acid exposure time percentage > 4%;
  6. Women of childbearing age or significant other male subjects of childbearing age are willing to use effective measures throughout the study period, such as oral, implanted, or injected contraceptive hormones, or use mechanical products such as intrauterine devices or barrier methods (uterine caps, , spermicides), or practice abstinence or self/significant other sterilization (such as vasectomy, hysterectomy, bilateral salpinectomy, or bilateral oophorectomy).

Exclusion criteria

Exclusion Criteria:

  1. Known to be allergic to the test drug and any of its components or to esomeprazole magnesium and its components;
  2. Those who cannot accept upper gastrointestinal endoscopy;
  3. Patients with gastroesophageal varices, hiatal hernia, Zollinger-Ellison syndrome, achalasia, irritable bowel syndrome or inflammatory bowel disease;
  4. History of eosinophilic esophagitis and Barrett's esophagus (≥ 3cm), confirmed by upper gastrointestinal endoscopy during the screening period;
  5. Screening for patients with active peptic ulcers and active upper/lower gastrointestinal bleeding within the first 3 months; or patients with a history of active peptic ulcers and active upper/lower gastrointestinal bleeding more than 3 months after screening, and those who did not recover after endoscopic examination of the upper gastrointestinal tract during the screening period;
  6. Patients with concomitant diseases that may affect esophageal motility (such as scleroderma, viral infection or fungal infection, etc.), or those with a history of esophageal radiotherapy or cryotherapy;
  7. Have undergone surgery to reduce gastric acid secretion, or any surgery that affects the structure or function of the esophagus, stomach, or duodenum (except for benign tumor resection, benign polyp endoscopic resection, simple suture surgery such as gastric perforation);
  8. Subjects with warning symptoms of upper gastrointestinal or gastrointestinal malignancies (such as swallowing pain, severe dysphagia, bleeding, weight loss, anemia, hemoptysis or hematochezia) (except for those with negative endoscopic malignancies);
  9. People with a history of the following diseases:

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)).

  1. Subjects who have taken gastric acid inhibitors (e.g. P-CAB, PPI) within 2 weeks before the first dose; or subjects who have taken H2 receptor blockers within 1 week before the first dose; 13. Subjects who were using retroviral antiviral drugs such as azanavir and nefinavir at the time of screening; 14. Those who meet any of the following requirements during the screening: Serum creatinine > 1.5 × ; history of chronic kidney disease, estimated (eGFR) \< 30ml/min/1.73m2.

Total > 1.5 × ULN, (AST)/aspartate aminotransferase (ALT) > 3 × ULN.

  1. Have participated in any systemic therapeutic drug clinical trial (defined as administered) within the first 3 months of screening or within 5 half-lives of the test drug (whichever is longer); 16. Pregnant or lactating women; 17. The investigator determines that the subjects are not suitable to participate in this experiment.
Terms in these criteria, in plain language(12)

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.

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.

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.

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.

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.

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

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.

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.

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.

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.

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.

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.

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
356 participants (estimated)

Study arms

  • Experimental
    JP-1366 Tablets

    20 mg qd, last for 4-8 weeks

    Drug: Esomeprazole Magnesium (Nexium) simulation tablets

  • Active comparator
    Esomeprazole magnesium Enteric Tablets

    40 mg qd, last for 4-8 weeks

    Drug: JP-1366 simulation tablets

Interventions

06

What researchers measure

Primary outcomes

  1. Percentage of subjects with esophageal mucosal healing confirmed by upper gastrointestinal endoscopy within 8 weeks of treatment

    Time frame: Week 4-8

Secondary outcomes

  1. Percentage of subjects with esophageal mucosal healing confirmed by upper gastrointestinal endoscopy within 4 weeks of treatment

    Time frame: Week 0-4

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Other outcomes

  1. 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

  2. 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

  3. The first time there were no major symptoms (heartburn and reflux) for 7 consecutive days after treatment

    Time frame: Week0-4 or Week0-8

07

Study locations

1 of 1 sites recruiting
  • Beijing Friendship Hospital, Capital Medical Universtiy
    Beijing, Beijing 100050, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06850480
Responsible party
Sponsor
First posted
Feb 27, 2025
Start date
Dec 5, 2024
Primary completion
Apr 15, 2025 (estimated)
Completion
Apr 30, 2025 (estimated)
Last update
Feb 27, 2025

Study contacts

Shutian Zhang, Dr.
Contact
zhangst@ccmu.edu.cn
+86-010-63016616

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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