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Tests treatment safety and results for Reflux Esophagitis (RE)
Official title A Phase III Clinical Trial for Efficacy and Safety Evaluation of JP-1366 Tablets on Reflux Esophagitis
ClinicalTrials.gov ID: NCT06850480
What this study is testing
What is JP-1366 simulation tablets?
JP-1366 simulation tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for reflux esophagitis (re).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy and safety of JP-1366 tablets and Nexium® (Esomeprazole magnesium enteric-coated tablets) in subjects with reflux esophagitis.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Voluntarily participate and sign a written informed consent form, and be able to understand the information provided and comply with the program...
- 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...
- Screening period for upper gastrointestinal endoscopy, diagnosed with grade A-D reflux esophagitis in Los Angeles (those who have received endoscopic...
- LA-A level people, esophageal reflux monitoring during the screening period, acid exposure time percentage \> 4%;
You likely can't join if
- 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...
- Patients with concomitant diseases that may affect esophageal motility (such as scleroderma, viral infection or fungal infection, etc.), or those...
See the full eligibility criteria
- 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...
- LA-A level people, esophageal reflux monitoring during the screening period, acid exposure time percentage \> 4%;
- Women of childbearing age or significant other male people of childbearing age are willing to use effective contraceptive measures throughout the study period, such as oral, implanted, or injected contraceptive...
- 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...
- 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;
- 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...
- people 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.