NCT04215653 is a Phase 3 clinical trial of Anaprazole Sodium in Duodenal Ulcer，DU, sponsored by Sihuan Pharmaceutical Holdings Group Ltd..

Who is sponsoring NCT04215653?

NCT04215653 is sponsored by Sihuan Pharmaceutical Holdings Group Ltd..

What drugs are being tested in NCT04215653?

Interventions in NCT04215653: Anaprazole Sodium, Rabeprazole, Rabeprazole Placebo, Anaprazole Sodium Placebo.

What condition does NCT04215653 study?

NCT04215653 studies Duodenal Ulcer，DU.

Is NCT04215653 still recruiting?

NCT04215653 is currently status unknown. Last updated 2 January 2020.

Last reviewed 2020-01-02 · How we verify

NCT04215653

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 3 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.

Status unknown Phase 3 Last updated 2 January 2020

What this trial tests

Phase 3 trial testing Anaprazole Sodium in Duodenal Ulcer，DU in 448 participants. Status unknown.

Timeline

20 January 2020

Primary endpoint
15 February 2021

28 February 2021

Quick facts

Lead sponsor	Sihuan Pharmaceutical Holdings Group Ltd.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	448
Start date	20 January 2020
Primary completion	15 February 2021
Estimated completion	28 February 2021

Drugs / interventions tested

Anaprazole Sodium — full drug profile →
Rabeprazole — full drug profile →
Rabeprazole Placebo — full drug profile →
Anaprazole Sodium Placebo — 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

Adults 18 to 70, any sex, with Duodenal Ulcer，DU. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Effect and safety of anaprazole in the treatment of duodenal ulcers: a randomized, rabeprazole-controlled, phase III non-inferiority study.
Zhu H, Pan X, Zhang L, Sun H, et al · · 2022 · cited 10× · PMID 36580650 · DOI 10.1097/cm9.0000000000002508
Cost-effectiveness analysis of Anaprazole versus Ilaprazole for the treatment of duodenal ulcers in China.
Ni H, Shi J, Hu M, Zhou N, et al · · 2024 · PMID 38910891 · DOI 10.3389/fphar.2024.1407435

Verify or expand the search:

Other trials of Anaprazole Sodium

Trials testing the same drug.

NCT04444011 — Pharmacokinetic Interactions of Quadruple Therapy With Anaprazole/Amoxicilin/Clarithromycin/Bismuth · Phase 1 · unknown
NCT04503629 — A Phase 2 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers. · Phase 2 · completed
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
NCT04200261 — Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem in Clinical Healthy Subjects · Phase 1 · unknown
NCT03851432 — Janagliflozin Treat Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Metformin · Phase 3 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04215653 (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: 2 January 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/NCT04215653.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing