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NCT04503629
A Phase 2 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.
Phase 2 trial testing Anaprazole Sodium in Duodenal Ulcer，DU in 150 participants. Completed in 17 May 2019.
17 May 2019
Quick facts
| Lead sponsor | Sihuan Pharmaceutical Holdings Group Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 9 October 2018 |
| Primary completion | 17 May 2019 |
| Estimated completion | 17 May 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
- Anaprazole Sodium — full drug profile →
- Anaprazole Sodium — full drug profile →
- Rabeprazole sodium — full drug profile →
Conditions studied
- Duodenal Ulcer，DU — all drugs for Duodenal Ulcer，DU →
Sponsor
Sihuan Pharmaceutical Holdings Group Ltd. — full company profile →
Who can join
18 and older, any sex, with Duodenal Ulcer，DU. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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.
Shu X, Zhu Z, Fu Y, Zhang Z, et al · · 2021 · cited 7× · PMID 34336894 · DOI 10.3389/fmed.2021.690995
Verify or expand the search:
- PubMed search for NCT04503629
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Anaprazole Sodium
Trials testing the same drug.
- NCT04444011 — Pharmacokinetic Interactions of Quadruple Therapy With Anaprazole/Amoxicilin/Clarithromycin/Bismuth · Phase 1 · unknown
- NCT04215653 — A Phase 3 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers. · Phase 3 · unknown
- NCT04467060 — A Single Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects · Phase 1 · completed
Other Sihuan Pharmaceutical Holdings Group Ltd. trials
Trials by the same sponsor.
- NCT04622072 — XZP-5809-TT1 Tablets in Patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer · Phase 1 · terminated
- NCT04476394 — Open-label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of [14C]-20 mg/ · Phase 1 · unknown
- NCT04444011 — Pharmacokinetic Interactions of Quadruple Therapy With Anaprazole/Amoxicilin/Clarithromycin/Bismuth · Phase 1 · unknown
- NCT04215653 — A Phase 3 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers. · Phase 3 · unknown
- NCT04200261 — Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem in Clinical Healthy Subjects · Phase 1 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04503629 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sihuan Pharmaceutical Holdings Group Ltd.
- Last refreshed: 7 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04503629.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing