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

NCT04215653 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2020-01-02

No results posted yet for this study

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.

Conditions

  • Duodenal Ulcer，DU

Interventions

DRUG

Anaprazole Sodium

administered orally once every 30-60 minutes before breakfast for 4 weeks

DRUG

Rabeprazole

administered orally once every 30-60 minutes before breakfast for 4 weeks

DRUG

Rabeprazole Placebo

administered orally once every 30-60 minutes before breakfast for 4 weeks

DRUG

Anaprazole Sodium Placebo

administered orally once every 30-60 minutes before breakfast for 4 weeks

Sponsors & Collaborators

  • Sihuan Pharmaceutical Holdings Group Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2021-02-15
Completion
2021-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04215653 on ClinicalTrials.gov