A Phase 3 interventional study of Anaprazole + Rabeprazole placebo and Rabeprazole + Anaprazole placebo in Reflux Esophagitis (RE), sponsored by Xuanzhu Biopharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by Xuanzhu Biopharmaceutical Co., Ltd. (part of Sihuan Pharmaceutical Holdings Group Ltd.) · Phase 3, Interventional, and Treatment
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Among 18 studies in Esophagitis, Peptic with a site in China — 8 open to participants now, 8 under way, 2 of them phase 3. Esophagitis, Peptic · China.
Among the 18 studies in Esophagitis, Peptic with a site in China, this one has the largest planned enrollment of the 15 interventional ones that give a count, is one of 3 that started in 2025, is one of 4 in phase 3, and was the 14th registered.
83 studies on the registry are indexed under Esophagitis, Peptic; 16 are open to participants now.
Browse Esophagitis, Peptic studies →8 of the 18 studies in Esophagitis, Peptic with a site in China are open now. Recruiting first, the newest first:
Jilin University · Sites in China
Ages 18+
Livzon Pharmaceutical Group Inc. · Sites in China
Ages 18–75
Northern Jiangsu People's Hospital · Sites in China
Ages 18–75
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 20–80
The First Affiliated Hospital with Nanjing Medical University · Sites in China, Russia
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 8 Esophagitis, Peptic studies recruiting now, 3 set no upper age limit and 3 stop at 75 or younger; none take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
18 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 3 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 500 is above the median of 135 across 60 interventional studies indexed under Esophagitis, Peptic.
Median enrollment 90 across the 15 interventional studies, 250 across the 3 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 18 have an industry lead sponsor. The 10 most frequent:
This study is registered under Xuanzhu Biopharmaceutical Co., Ltd., one of the names counted as Sihuan Pharmaceutical Holdings Group Ltd.. Under that name alone:
Xuanzhu Biopharmaceutical Co., Ltd. is the lead sponsor of 24 studies on the registry; 11 are open to participants now.
Sihuan Pharmaceutical Holdings Group Ltd. has 2 studies filed under Esophagitis, Peptic — fewer than ten, so there is no comparison to draw.
2 of the studies in Esophagitis, Peptic with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05892289Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityFeasibility and Safety of Robotic Assisted Proximal Gastrectomy With Double-flap Technique for Proximal Early Gastric Cancer | 2026-12-10 |
| NCT07800819The First Affiliated Hospital with Nanjing Medical UniversitySino-Russian Comparison of Outcomes After Proximal Gastrectomy With Double-Tract Reconstruction | 2027-06-15 |
Add all 2 to your calendar (.ics) → With an account.
Among the 18 studies in Esophagitis, Peptic with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This Phase III clinical trial is designed to assess the efficacy and safety of Anaprazole 60 mg once daily (QD) administered over a period of up to 8 weeks, compared with Rabeprazole 20 mg QD, in patients with reflux esophagitis.
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.
Exclusion Criteria:
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.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
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.
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.
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.
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anaprazole 3 tablets (20 mg/tablet) + Rabeprazole placebo 1 tablet (0.16 g/tablet), administered orally 30-60 minutes before breakfast once daily for up to 8 weeks. After 4 weeks of continuous treatment, if endoscopic evaluation confirms the cure of reflux esophagitis, treatment may be discontinued.
Drug: Anaprazole + Rabeprazole placebo
Rabeprazole 1 tablet (20 mg/tablet) + Anaprazole placebo 3 tablets (0.2 g/tablet), orally administered 30-60 minutes before breakfast once daily for up to 8 weeks. After 4 weeks of continuous treatment, if endoscopic evaluation confirms the cure of reflux esophagitis, treatment may be discontinued.
Drug: Rabeprazole + Anaprazole placebo
Anaprazole 3 tablets (20 mg/tablet) + Rabeprazole placebo 1 tablet (0.16 g/tablet), administered orally 30-60 minutes before breakfast once daily for up to 8 weeks. After 4 weeks of continuous treatment, if endoscopic evaluation confirms the cure of reflux esophagitis, treatment may be discontinued.
Rabeprazole 1 tablet (20 mg/tablet) + Anaprazole placebo 3 tablets (0.2 g/tablet), orally administered 30-60 minutes before breakfast once daily for up to 8 weeks. After 4 weeks of continuous treatment, if endoscopic evaluation confirms the cure of reflux esophagitis, treatment may be discontinued.
The endoscopic healing rate of reflux esophagitis
The endoscopic healing rate of reflux esophagitis is defined as the proportion of patients with reflux esophagitis who achieve complete mucosal healing. Complete healing is determined by the absence of mucosal breaks upon endoscopic evaluation post-treatment, and the lesion is classified as normal according to the LA classification.
Time frame: Up to 8 weeks
The endoscopic healing rate of reflux esophagitis
The endoscopic healing rate of reflux esophagitis is defined as the proportion of patients with reflux esophagitis who achieve complete mucosal healing. Complete healing is determined by the absence of mucosal breaks upon endoscopic evaluation post-treatment, and the lesion is classified as normal according to the LA classification.
Time frame: Up to 4 weeks
Changes in the severity and frequency of heartburn compared to the baseline
The analysis was performed using a symptom assessment questionnaire. On Day 1 of treatment, participants reported their symptoms experienced during the 7 days prior to randomization. On Days 29 and 57 of treatment, and visits for early trial withdrawal, symptom data were recorded based on the completion status of the 7-day diary cards filled out by participants immediately preceding each visit. The severity of heartburn was evaluated using a 4-point scale, while the frequency of occurrence of heartburn was assessed using a 5-point scale.
Time frame: Up to 8 weeks
Changes in the severity and frequency of reflux compared to the baseline
The analysis was performed using a symptom assessment questionnaire. On Day 1 of treatment, participants reported their symptoms experienced during the 7 days prior to randomization. On Days 29 and 57 of treatment, and visits for early trial withdrawal, symptom data were recorded based on the completion status of the 7-day diary cards filled out by participants immediately preceding each visit. The severity of reflux was evaluated using a 4-point scale, while the frequency of occurrence of reflux was assessed using a 5-point scale.
Time frame: Up to 8 weeks
The rate of improvement in the severity and frequency of heartburn
Standard for evaluating improvement in severity of individual symptoms: Calculate the average severity score for the 7 days prior to the 4-week and 8-week visits separately. The average score = total of individual scores recorded within 7 days / number of recording days. * Complete remission: The average score drops to 0 points * Improvement: The average score decreases by at least 1 point * No effect: The average score remains unchanged or increases. Standard for scoring the frequency of individual symptoms: 0 points: 0 days; 1 point: 1 day; 2 points: 2-3 days; 3 points: 4-5 days; 4 points: 6-7 days; The improvement rate of individual symptom severity/frequency = (Number of improved cases / Total number of cases) × 100%.
Time frame: Up to 8 weeks
The rate of improvement in the severity and frequency of reflux
Standard for evaluating improvement in severity of individual symptoms: Calculate the average severity score for the 7 days prior to the 4-week and 8-week visits separately. The average score = total of individual scores recorded within 7 days / number of recording days. * Complete remission: The average score drops to 0 points * Improvement: The average score decreases by at least 1 point * No effect: The average score remains unchanged or increases. Standard for scoring the frequency of individual symptoms: 0 points: 0 days; 1 point: 1 day; 2 points: 2-3 days; 3 points: 4-5 days; 4 points: 6-7 days; The improvement rate of individual symptom severity/frequency = (Number of improved cases / Total number of cases) × 100%.
Time frame: Up to 8 weeks
Change from baseline in the Gastroesophageal Reflux Disease Health-Related Quality of Life Questionnaire (GERD-HRQL) score
GERD related quality of life (QoL) is assessed with the "gastroesophageal reflux disease - health related quality of life" (GERD-HRQL) questionnaire. QoL is measured at baseline, Days 29 and 57 of treatment, and visits for early trial withdrawal. The scale contains 10 questions and a symptom control satisfaction survey, which focuses on heartburn, acid reflux, swallowing function, and drug efficacy. Each question is scored according to a 6-point scoring criterion (0 indicates no symptoms, 5 indicates intolerable symptoms, and affects daily activities), and the total score is the sum of the scores of each item (0-50 points in total), with higher scores indicating worse quality of life. Satisfaction is divided into three levels: dissatisfaction, moderate, and satisfaction. Change in GERD-HRQL score = total GERD-HRQL score after treatment - total GERD-HRQL score before treatment.
Time frame: Up to 8 weeks
Adverse events
The treatment-emergent adverse events are evaluated by CTCAE v5.0
Time frame: Up to 8 weeks
Started Jul 2025 (actual). Primary completion is estimated for Apr 2026, 9 months after the start.
How these figures are worked out, and which studies are left out of them.
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Xuanzhu Biopharmaceutical Co., Ltd. →