Duodenal Ulcer，DUPhase 2NCT04503629
A Phase 2 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.
A Phase 2 study testing Anaprazole Sodium and Rabeprazole sodium in people with Duodenal Ulcer，DU, run by Sihuan Pharmaceutical Holdings Group Ltd. at 1 site in China.
Trial summary
A phase 2,double-blinded, double dummy, parallel, positive drug, randomised controlled multicenter trial to evaluate efficacy and safety of 4 weeks treatment of Anaprazole 20mg QD, 40mg QD compared with rabeprazole 10mg QD in patients with duodenal ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Duodenal Ulcer，DU
- What is being tested?
- Anaprazole Sodium and Rabeprazole sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2018to 17 May 2019
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 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 other gastrointestinal disease (e.g.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；
Show all 17Show fewer
- 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)；
- 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, or mental or psychological disorders with drug treatment that,in the opinion of the investigator, would not be suitable for participating this clinical trial.
- In the opinion of the investigator, the patients with other situation would not be suitable for participating this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The Fisrst Affiliated Hospital of NanChang University
Nanchang, Jiangxi, 330006
About this study
Official title: A Phase 2,Double-blinded, Double Dummy, Positive Drug, Parallel, Randomised Controlled Multicenter Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.
A phase 2,double-blinded, double dummy, parallel, positive drug, randomised controlled multicenter trial to evaluate efficacy and safety of 4 weeks treatment of Anaprazole 20mg QD, 40mg QD compared with rabeprazole 10mg QD in patients with duodenal ulcers.
- Conditions
- Duodenal Ulcer，DU
- Being tested
- Anaprazole Sodium, Rabeprazole sodium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anaprazole SodiumDrug
Anaprazole Sodium 20mg
Anaprazole SodiumDrug
Anaprazole Sodium 40mg
Rabeprazole sodiumDrug
Rabeprazole sodium 10mg
| Study group | Role | What they receive |
|---|---|---|
| Anaprazole Sodium 20mg QD | Experimental | administered orally once every 30-60 minutes before breakfast for 4 weeks Receives: Drug: Anaprazole Sodium |
| Anaprazole Sodium 40mg QD | Experimental | administered orally once every 30-60 minutes before breakfast for 4 weeks Receives: Drug: Anaprazole Sodium |
| Rabeprazole sodium 10mg QD | Active comparator | administered orally once every 30-60 minutes before breakfast for 4 weeks Receives: Drug: Rabeprazole sodium |
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.
The endoscopic ulcer healing rate is defined as the percentage of patients with endoscopic ulcer healed 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 posted7 Aug 2020
- Study start9 Oct 2018
- Primary completion17 May 2019
- Study completion17 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
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
- NCT04503629
- Sponsor's protocol ID
- 3571-DU-2001
- Status last verified
- Aug 2020
- First submitted
- 5 Aug 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shu X, Zhu Z, Fu Y, Zhang Z, Wang J, Li X, He S, Fan H, Liu S, Zhang G, Tang J, Huang C, Du Q, Wang X, Xu B, Du Y, Chen Q, Wang B, Chen Y, Duan X, Xie Y, Huo L, Hou X, Lu N. Mucosal Healing Effectiveness and Safety of Anaprazole, a Novel PPI, vs. Rabeprazole in Patients With Duodenal Ulcers: A Randomized Double-Blinded Multicenter Phase II Clinical Trial. Front Med (Lausanne). 2021 Jul 14;8:690995. doi: 10.3389/fmed.2021.690995. eCollection 2021.
PubMed 34336894
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2,Double-blinded, Double Dummy, Positive Drug, Parallel, Randomised Controlled Multicenter Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.
- ClinicalTrials.gov ID
- NCT04503629
- Acronym / sponsor ID
- 3571-DU-2001
- Conditions
- Duodenal Ulcer，DU
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 7 Aug 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 2,double-blinded, double dummy, parallel, positive drug, randomised controlled multicenter trial to evaluate efficacy and safety of 4 weeks treatment of Anaprazole 20mg QD, 40mg 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Anaprazole Sodium 20mg QD | Experimental | Drug: Anaprazole Sodiumadministered orally once every 30-60 minutes before breakfast for 4 weeks |
| Anaprazole Sodium 40mg QD | Experimental | Drug: Anaprazole Sodiumadministered orally once every 30-60 minutes before breakfast for 4 weeks |
| Rabeprazole sodium 10mg QD | Active comparator | Drug: Rabeprazole sodiumadministered orally once every 30-60 minutes before breakfast for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 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 (17 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 other gastrointestinal disease (e.g.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 SodiumAnaprazole Sodium 20mg | Drug | Anaprazole Sodium 20mg QD |
| Anaprazole SodiumAnaprazole Sodium 40mg | Drug | Anaprazole Sodium 40mg QD |
| Rabeprazole sodiumRabeprazole sodium 10mg | Drug | Rabeprazole sodium 10mg QD |
Primary outcome
The endoscopic healing rate of duodenal ulcers at week 4.
Time frame: Treatment of 4 weeks
The endoscopic ulcer healing rate is defined as the percentage of patients with endoscopic ulcer healed evaluated by investigators.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Derived from this study: PubMed 34336894Shu X, Zhu Z, Fu Y, Zhang Z, Wang J, Li X, He S, Fan H, Liu S, Zhang G, Tang J, Huang C, Du Q, Wang X, Xu B, Du Y, Chen Q, Wang B, Chen Y, Duan X, Xie Y, Huo L, Hou X, Lu N. Mucosal Healing Effectiveness and Safety of Anaprazole, a Novel PPI, vs. Rabeprazole in Patients With Duodenal Ulcers: A Randomized Double-Blinded Multicenter Phase II Clinical Trial. Front Med (Lausanne). 2021 Jul 14;8:690995. doi: 10.3389/fmed.2021.690995. eCollection 2021.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anaprazole Sodium and Rabeprazole sodium in people with Duodenal Ulcer，DU, run by Sihuan Pharmaceutical Holdings Group Ltd. at 1 site in China.
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 17 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: finished, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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. (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 NCT04503629, which also lists 1 linked publication.
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 7 Aug 2020; AzTrials last refreshed its copy on 28 Oct 2026.