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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JP-1366 Tablets | Experimental | 20 mg qd, last for 4-8 weeks |
|
| Esomeprazole magnesium Enteric Tablets | Active Comparator | 40 mg qd, last for 4-8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JP-1366 simulation tablets | Drug | qd, last for 4-8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with esophageal mucosal healing confirmed by upper gastrointestinal endoscopy within 8 weeks of treatment | Week 4-8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with esophageal mucosal healing confirmed by upper gastrointestinal endoscopy within 4 weeks of treatment | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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) |
Inclusion Criteria:
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; 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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shutian Zhang, Dr. | Contact | +86-010-63016616 | zhangst@ccmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical Universtiy | Recruiting | Beijing | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| D004942 | Esophagitis, Peptic |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Esomeprazole Magnesium (Nexium) simulation tablets |
| Drug |
qd, last for 4-8 weeks |
|
| 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. | 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. | 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 | 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. | 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 | Week0-5 or Week 0-9 |
| Week0-4 or Week0-8 |
| The first time there were no major symptoms (heartburn and reflux) for 7 consecutive days after treatment | Week0-4 or Week0-8 |
| D005759 |
| Gastroenteritis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |