NCT04215653

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

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.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 448 (estimated)
• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-01-20
• Primary completion: 2021-02-15
• Completion: 2021-02-28
• First posted: 2020-01-02
• Last updated: 2020-01-02