New acid reflux pill aims to heal esophagus faster
NCT ID NCT07010107
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new medicine called anaprazole to see if it heals the esophagus better than a standard treatment (rabeprazole) in people with reflux esophagitis. About 500 adults with moderate to severe esophagus damage will take either anaprazole or rabeprazole daily for up to 8 weeks. The main goal is to check if the esophagus lining fully heals after treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The patients provided voluntary signed informed consent forms. 2. Aged ≥18 years and ≤75 years old. 3. Endoscopically diagnosed as reflux esophagitis (LA grade B-D) within 14 days before randomization. Exclusion Criteria: 1. Researchers believe that patients with uncontrolled primary diseases are not suitable for clinical trials, particularly those with a history of severe conditions affecting the cardiovascular, nervous, respiratory, hepatic, renal, or other systems. 2. Patients with concomitant diseases that may affect the esophagus or esophageal motility and, could potentially influence the efficacy evaluation. 3. Patients with a history of prior surgical procedures that could potentially impact esophageal function, or surgeries. 4. Patients confirmed to have active peptic ulcers or active upper/lower gastrointestinal bleeding within the last 30 days via esophagogastroduodenoscopy (EGD). 5. Patients with a history of Zollinger-Ellison syndrome, achalasia of the cardia, secondary esophageal motility disorders, irritable bowel syndrome, inflammatory bowel disease, or other gastrointestinal functional disorders. 6. Patients with a history of malignant tumor or having received treatment for malignant tumor within 5 years prior to randomization. 7. Patients with a history of mental illness or a history of drug or alcohol abuse within 12 months prior to screening. 8. Patients who tested positive for HIV, HBsAg, and/or HCV antibodies during screening. 9. Patients with malignant tumors or a predisposition to malignancy in the stomach or esophagus. 10. Patients with abnormal liver function: AST and/or ALT levels ≥2.0×ULN, and/or total bilirubin (TBIL) levels ≥1.5×ULN. 11. Patients with abnormal renal function: Serum creatinine levels ≥1.5×ULN, blood urea or blood urea nitrogen levels ≥1.5×ULN. 12. Patients with clinically significant ECG abnormalities, including QTc interval prolongation (QTcF ≥450 ms for men and QTcF ≥470 ms for women). 13. Patients with poorly controlled diabetes or hypertension. 14. Patients who were unable to undergo esophagogastroduodenoscopy (EGD). 15. Patients with a known allergy to the components or ingredients of Anaprazole or Rabeprazole. 16. Patients who had used proton pump inhibitors at therapeutic doses within 14 days prior to randomization. 17. Patients who had used therapeutic doses of other drugs for treating acid reflux within 7 days prior to randomization. 18. Patients required to continue receiving non-steroidal anti-inflammatory drugs (NSAIDs), systemic glucocorticoids, or clopidogrel during the trial period. 19. Patients whose assessment may be affected by alcohol, drug, or medication withdrawal during the study. 20. Pregnant or lactating women, as well as patients planning to conceive within 30 days before randomization and up to 6 months following the trial completion. 21. Patients who had participated in other drug clinical trials within 3 months prior to randomization. 22. Patients with other conditions deemed by the researchers as unsuitable for participation in this clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Changhai Hospital
RECRUITINGShanghai, Shanghai Municipality, 200433, China
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