Reflux Esophagitis (RE)Phase 3NCT06850480
A Phase III Clinical Trial for Efficacy and Safety Evaluation of JP-1366 Tablets on Reflux Esophagitis
A Phase 3 study testing JP-1366 simulation tablets and Esomeprazole Magnesium (Nexium) simulation tablets in people with Reflux Esophagitis (RE), run by Livzon Pharmaceutical Group Inc. at 1 site in China.
Trial summary
To evaluate the efficacy and safety of JP-1366 tablets and Nexium® (Esomeprazole magnesium enteric-coated tablets) in subjects with reflux esophagitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Reflux Esophagitis (RE)
- What is being tested?
- JP-1366 simulation tablets and Esomeprazole Magnesium (Nexium) simulation tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2024to 30 Apr 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate and sign a written informed consent form, and be able to understand the information provided and comply with the program requirements;
- Age between 18-75 years old (including boundary values) during screening, both male and female are acceptable.
- 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;
- 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).
- LA-A level subjects, esophageal reflux monitoring during the screening period, acid exposure time percentage > 4%;
- Women of childbearing age or significant other male subjects of childbearing age are willing to use effective contraceptive 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).
Who cannot join
- Known to be allergic to the test drug and any of its components or to esomeprazole magnesium and its components;
- Those who cannot accept upper gastrointestinal endoscopy;
- Patients with gastroesophageal varices, hiatal hernia, Zollinger-Ellison syndrome, achalasia, irritable bowel syndrome or inflammatory bowel disease;
- History of eosinophilic esophagitis and Barrett's esophagus (≥ 3cm), confirmed by upper gastrointestinal endoscopy during the screening period;
- 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;
- 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;
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- 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);
- Subjects with warning symptoms of upper gastrointestinal malignancies or gastrointestinal malignancies (such as swallowing pain, severe dysphagia, bleeding, weight loss, anemia, hemoptysis or hematochezia) (except for those with negative endoscopic malignancies);
- People with a history of the following clinically significant 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; transient ischemic attack or ischemic stroke.
- Patients with a history of chronic congestive heart failure and NYHA 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 QTc interval 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 corticosteroids, or antithrombotic drugs during the trial period (excluding those who use prophylactic low-dose aspirin (≤ 100mg/day)).
- 12. 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 × ULN; history of chronic kidney disease, estimated glomerular filtration rate (eGFR) < 30ml/min/1.73m2.
- Total bilirubin > 1.5 × ULN, alanine aminotransferase (AST)/aspartate aminotransferase (ALT) > 3 × ULN.
- 15. 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical Universtiy
Beijing, Beijing Municipality, 100050
Shutian Zhang, Dr., +86-010-63016616, zhangst@ccmu.edu.cn
About this study
Official title: A Multicenter, Randomized, Double-blind, Double-simulated, Positive Parallel-control Phase III Clinical Trails of JP-1366（Zastaprazan Citrate） Tablets and Nexium® on Reflux Esophagitis
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.
- Conditions
- Reflux Esophagitis (RE)
- Being tested
- JP-1366 simulation tablets, Esomeprazole Magnesium (Nexium) simulation tablets
- Medical subject headings
- Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JP-1366 simulation tabletsDrug
qd, last for 4-8 weeks
Esomeprazole Magnesium (Nexium) simulation tabletsDrug
qd, last for 4-8 weeks
| Study group | Role | What they receive |
|---|---|---|
| JP-1366 Tablets | Experimental | 20 mg qd, last for 4-8 weeks Receives: Drug: Esomeprazole Magnesium (Nexium) simulation tablets |
| Esomeprazole magnesium Enteric Tablets | Active comparator | 40 mg qd, last for 4-8 weeks Receives: Drug: JP-1366 simulation tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with esophageal mucosal healing confirmed by upper gastrointestinal endoscopy within 8 weeks of treatment
Measured: Week 4-8
Secondary outcomes (7)
Percentage of subjects with esophageal mucosal healing confirmed by upper gastrointestinal endoscopy within 4 weeks of treatment
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Week0-5 or Week 0-9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start5 Dec 2024
- Primary completion15 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reflux Esophagitis (RE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Livzon Pharmaceutical Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850480
- Sponsor's protocol ID
- LZ031-301
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Double-simulated, Positive Parallel-control Phase III Clinical Trails of JP-1366（Zastaprazan Citrate） Tablets and Nexium® on Reflux Esophagitis
- ClinicalTrials.gov ID
- NCT06850480
- Acronym / sponsor ID
- LZ031-301
- Conditions
- Reflux Esophagitis (RE)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Livzon Pharmaceutical Group Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of JP-1366 tablets and Nexium® (Esomeprazole magnesium enteric-coated tablets) in subjects with reflux esophagitis.
Detailed description
To evaluate the efficacy and safety of JP-1366 tablets and Nexium® (Esomeprazole magnesium enteric-coated tablets) in subjects with reflux esophagitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JP-1366 Tablets | Experimental | Drug: Esomeprazole Magnesium (Nexium) simulation tablets20 mg qd, last for 4-8 weeks |
| Esomeprazole magnesium Enteric Tablets | Active comparator | Drug: JP-1366 simulation tablets40 mg qd, last for 4-8 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily participate and sign a written informed consent form, and be able to understand the information provided and comply with the program requirements;
- Age between 18-75 years old (including boundary values) during screening, both male and female are acceptable.
- 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;
- 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).
- LA-A level subjects, esophageal reflux monitoring during the screening period, acid exposure time percentage > 4%;
Key exclusion criteria (20 listed)
- Known to be allergic to the test drug and any of its components or to esomeprazole magnesium and its components;
- Those who cannot accept upper gastrointestinal endoscopy;
- Patients with gastroesophageal varices, hiatal hernia, Zollinger-Ellison syndrome, achalasia, irritable bowel syndrome or inflammatory bowel disease;
- History of eosinophilic esophagitis and Barrett's esophagus (≥ 3cm), confirmed by upper gastrointestinal endoscopy during the screening period;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JP-1366 simulation tabletsqd, last for 4-8 weeks | Drug | Esomeprazole magnesium Enteric Tablets |
| Esomeprazole Magnesium (Nexium) simulation tabletsqd, last for 4-8 weeks | Drug | JP-1366 Tablets |
Primary outcome
Percentage of subjects with esophageal mucosal healing confirmed by upper gastrointestinal endoscopy within 8 weeks of treatment
Time frame: Week 4-8
7 secondary outcomes
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
Time frame: Week 0-4 and week4-8
The proportion of positive answers to "treatment satisfaction" in the GERD-HRQL scale
Time frame: Week 0-8
Changes in RDQ questionnaire scores compared to the base line at 4 and 8 weeks after treatment
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JP-1366 simulation tablets and Esomeprazole Magnesium (Nexium) simulation tablets in people with Reflux Esophagitis (RE), run by Livzon Pharmaceutical Group Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shutian Zhang, Dr. (+86-010-63016616, zhangst@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with esophageal mucosal healing confirmed by upper gastrointestinal endoscopy within 8 weeks of treatment (time frame: Week 4-8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.