Duodenal Ulcer，DUPhase 3NCT04215653
A Phase 3 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.
A Phase 3 study testing Anaprazole Sodium and Rabeprazole in people with Duodenal Ulcer，DU, run by Sihuan Pharmaceutical Holdings Group Ltd..
Trial summary
A phase 3,double-blinded, double dummy, parallel, non-inferiority, randomised controlled multicenter trial to evaluate efficacy and safety of 4 weeks treatment of Anaprazole 20mg QD compared with rabeprazole 10mg QD in patients with duodenal ulcers. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Duodenal Ulcer，DU
- What is being tested?
- Anaprazole Sodium and Rabeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 448 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2020to 28 Feb 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years, male and female
- Has endoscopic diagnosis of active duodenal ulcer(s) (A1 or A2 stage) within 7 days prior to randomization
- 1 or 2 ulcers, 3-15 mm in diameter.
- Signed informed concent form
Who cannot join
- Has malignancy ulcer or malignancy ulcer not excluded, compouned ulcer, stress ulcer, esophageal erosion and ulcer, reflux esophagitis, Zollinger-Ellison syndrome.
- Has esophageal and gastric varices；
- With severe compliaction, such as pyloric obstruction, bleeding (Forrest I, IIa and IIb) or perforation, and etc；
- Has gastric ulcer, or has history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)；
- Has undergone surgical resection or partly resection of esophageal, stomach or duodenum；
- Has used Proton Pump Inhibitors(PPIs) within 5 days prior to randomization, or continuous more than 3 days of use of Proton Pump Inhibitors within 2 weeks prior to randomization；
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- Has been treated with triple or quandruple Helicobacter pylori eradication therapy included PPIs within 28 days prior to randomization；
- Current use the drugs (such as systemic glucocorticoids, non steroid anti-inflammatory drugs, or anticoagulation drugs) which may induce ulcer or ulceric bleeding or continuous more than 3 days of use the drugs (such as systemic glucocorticoids, non steroid anti-inflammatory drugs, or anticoagulation drugs) within 28 days prior to randomization；
- Laboratory tests performed in screning stage revealed Alanine aminotransferase (ALT) or aspartate aminotransferase (AST): > 1.5 upper limit of normal (ULN);
- Laboratory tests performed in screning stage revealed thyroid stimulating hormone (TSH) or free triiodothyronine (FT3) and free thyroxin ( FT4) : > upper limit of normal (ULN)；
- Woman in pregnancy or lactation period；
- Plan for pregancy or not willing to contracept with reliable contraception method during study period and within 90 days after the final time of investigational drug administratio；
- Have alcohol abuse or drug abuse 1 years prior to screening；
- Has hypersensitivity or allergy to investigatory drug, comparatory drug or related supplements；
- Has participated or been participating other clinical trials(non-interventional study is excluded)；
- Has an uncotroled disease, such as has a history of significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, gastrointestinal, or mental or psychological disorders with drug treatment that,in the opinion of the investigator, would not be suitable for participating this clinical trial.
- Has a history of malignancy or was treated or not treated for malignancy within 5 years before randomization (the participant may be included in the study if he/she has cured cutaneous basal cell carcinoma), no matter if there is evidence for local relapse or metastasis；
- Laboratory tests performed in screning stage revealed estimated Glomerular filtration rate（eGFR） <80 mL/min/1.73 m2 calculated by Modification of Diet in Renal Disease(MDRD) equation；
- In the opinion of the investigator, the patients with other situation would not be suitable for participating this clinical trial.
About this study
Official title: A Phase 3,Double-blinded, Double Dummy, Positive Drug, Parallel, Randomised Controlled Multicenter Trial to Evaluate Efficacy and Safety of Anaprazole Compared With Rabeprazole in Patients With Duodenal Ulcers.
A phase 3,double-blinded, double dummy, parallel, non-inferiority, randomised controlled multicenter trial to evaluate efficacy and safety of 4 weeks treatment of Anaprazole 20mg QD compared with rabeprazole 10mg QD in patients with duodenal ulcers.
- Conditions
- Duodenal Ulcer，DU
- Being tested
- Anaprazole Sodium, Rabeprazole, Rabeprazole Placebo, Anaprazole Sodium Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anaprazole SodiumDrug
administered orally once every 30-60 minutes before breakfast for 4 weeks
RabeprazoleDrug
administered orally once every 30-60 minutes before breakfast for 4 weeks
Rabeprazole PlaceboDrug
administered orally once every 30-60 minutes before breakfast for 4 weeks
Anaprazole Sodium PlaceboDrug
administered orally once every 30-60 minutes before breakfast for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Anaprazole Sodium + Rabeprazole Placebo | Experimental | administered orally once every 30-60 minutes before breakfast for 4 weeks Receives: Drug: Anaprazole Sodium; Drug: Rabeprazole Placebo |
| Rabeprazole +Anaprazole Sodium Placebo | Active comparator | administered orally once every 30-60 minutes before breakfast for 4 weeks Receives: Drug: Rabeprazole; Drug: Anaprazole Sodium Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The endoscopic healing rate of duodenal ulcers at week 4, evaluated by blinded independency central reading.
The endoscopic ulcer healing rate is defined as the percentage of patients healed (complete healing and significant response) in whom the endoscopic response of duodenal ulcers at week 4 has been evaluated by blinded independency central reading.
Measured: Treatment of 4 weeks
Secondary outcomes (1)
The endoscopic healing rate of duodenal ulcers at week 4, evaluated by investigator reading.
The endoscopic ulcer healing rate is defined as the percentage of patients healed (complete healing and significant response) in whom the endoscopic response of duodenal ulcers at week 4 has been evaluated by investigators.
Measured: Treatment of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start20 Jan 2020 (estimated)
- Primary completion15 Feb 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Duodenal Ulcer，DUStudies 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
- 448 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215653
- Sponsor's protocol ID
- 3571-DU-3001
- Status last verified
- Nov 2019
- First submitted
- 30 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ni H, Shi J, Hu M, Zhou N, Yang S. Cost-effectiveness analysis of Anaprazole versus Ilaprazole for the treatment of duodenal ulcers in China. Front Pharmacol. 2024 Jun 7;15:1407435. doi: 10.3389/fphar.2024.1407435. eCollection 2024.
PubMed 38910891Zhu H, Pan X, Zhang L, Sun H, Fan H, Pan Z, Huang C, Shi Z, Ding J, Wang Q, Du Y, Lyu N, Li Z. Effect and safety of anaprazole in the treatment of duodenal ulcers: a randomized, rabeprazole-controlled, phase III non-inferiority study. Chin Med J (Engl). 2022 Dec 20;135(24):2941-2949. doi: 10.1097/CM9.0000000000002508.
PubMed 36580650
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3,Double-blinded, Double Dummy, Positive Drug, Parallel, Randomised Controlled Multicenter Trial to Evaluate Efficacy and Safety of Anaprazole Compared With Rabeprazole in Patients With Duodenal Ulcers.
- ClinicalTrials.gov ID
- NCT04215653
- Acronym / sponsor ID
- 3571-DU-3001
- Conditions
- Duodenal Ulcer，DU
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 448 participants (estimated)
- Lead sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2020 (estimated)
- Primary completion
- 15 Feb 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 2 Jan 2020 (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.
A phase 3,double-blinded, double dummy, parallel, non-inferiority, randomised controlled multicenter trial to evaluate efficacy and safety of 4 weeks treatment of Anaprazole 20mg QD compared with rabeprazole 10mg QD in patients with duodenal ulcers.
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 |
|---|---|---|
| Anaprazole Sodium + Rabeprazole Placebo | Experimental | Drug: Anaprazole Sodium, Drug: Rabeprazole Placeboadministered orally once every 30-60 minutes before breakfast for 4 weeks |
| Rabeprazole +Anaprazole Sodium Placebo | Active comparator | Drug: Rabeprazole, Drug: Anaprazole Sodium Placeboadministered orally once every 30-60 minutes before breakfast for 4 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70 years, male and female
- Has endoscopic diagnosis of active duodenal ulcer(s) (A1 or A2 stage) within 7 days prior to randomization
- 1 or 2 ulcers, 3-15 mm in diameter.
- Signed informed concent form
Key exclusion criteria (19 listed)
- Has malignancy ulcer or malignancy ulcer not excluded, compouned ulcer, stress ulcer, esophageal erosion and ulcer, reflux esophagitis, Zollinger-Ellison syndrome.
- Has esophageal and gastric varices；
- With severe compliaction, such as pyloric obstruction, bleeding (Forrest I, IIa and IIb) or perforation, and etc；
- Has gastric ulcer, or has history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis)；
- Has undergone surgical resection or partly resection of esophageal, stomach or duodenum；
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 |
|---|---|---|
| Anaprazole Sodiumadministered orally once every 30-60 minutes before breakfast for 4 weeks | Drug | Anaprazole Sodium + Rabeprazole Placebo |
| Rabeprazoleadministered orally once every 30-60 minutes before breakfast for 4 weeks | Drug | Rabeprazole +Anaprazole Sodium Placebo |
| Rabeprazole Placeboadministered orally once every 30-60 minutes before breakfast for 4 weeks | Drug | Anaprazole Sodium + Rabeprazole Placebo |
| Anaprazole Sodium Placeboadministered orally once every 30-60 minutes before breakfast for 4 weeks | Drug | Rabeprazole +Anaprazole Sodium Placebo |
Primary outcome
The endoscopic healing rate of duodenal ulcers at week 4, evaluated by blinded independency central reading.
Time frame: Treatment of 4 weeks
The endoscopic ulcer healing rate is defined as the percentage of patients healed (complete healing and significant response) in whom the endoscopic response of duodenal ulcers at week 4 has been evaluated by blinded independency central reading.
1 secondary outcome
The endoscopic healing rate of duodenal ulcers at week 4, evaluated by investigator reading.
Time frame: Treatment of 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Derived from this study: PubMed 38910891Ni H, Shi J, Hu M, Zhou N, Yang S. Cost-effectiveness analysis of Anaprazole versus Ilaprazole for the treatment of duodenal ulcers in China. Front Pharmacol. 2024 Jun 7;15:1407435. doi: 10.3389/fphar.2024.1407435. eCollection 2024.
- Derived from this study: PubMed 36580650Zhu H, Pan X, Zhang L, Sun H, Fan H, Pan Z, Huang C, Shi Z, Ding J, Wang Q, Du Y, Lyu N, Li Z. Effect and safety of anaprazole in the treatment of duodenal ulcers: a randomized, rabeprazole-controlled, phase III non-inferiority study. Chin Med J (Engl). 2022 Dec 20;135(24):2941-2949. doi: 10.1097/CM9.0000000000002508.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anaprazole Sodium and Rabeprazole in people with Duodenal Ulcer，DU, run by Sihuan Pharmaceutical Holdings Group Ltd..
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 4 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The endoscopic healing rate of duodenal ulcers at week 4, evaluated by blinded independency central reading. (time frame: Treatment of 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04215653, which also lists 2 linked publications.
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 2 Jan 2020; AzTrials last refreshed its copy on 28 Oct 2026.