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

NCT04215653 | Unknown Phase 3 DMC

• 1 other identifier: 3571-DU-3001
• Study Type: interventional
• Target: 448
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• The endoscopic healing rate of duodenal ulcers at week 4, evaluated by blinded independency central reading.

  The endoscopic ulcer healing rate is defined as the percentage of patients healed (complete healing and significant response) in whom the endoscopic response of duodenal ulcers at week 4 has been evaluated by blinded independency central reading.

  Treatment of 4 weeks

Secondary Outcomes (1)

• The endoscopic healing rate of duodenal ulcers at week 4, evaluated by investigator reading.

  Treatment of 4 weeks

Study Arms (2)

Anaprazole Sodium + Rabeprazole Placebo

EXPERIMENTAL

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

Drug: Anaprazole Sodium; Drug: Rabeprazole Placebo

Rabeprazole +Anaprazole Sodium Placebo

ACTIVE COMPARATOR

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

Drug: Rabeprazole; Drug: Anaprazole Sodium Placebo

Interventions

Anaprazole Sodium DRUG

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

Anaprazole Sodium + Rabeprazole Placebo

Rabeprazole DRUG

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

Rabeprazole +Anaprazole Sodium Placebo

Rabeprazole Placebo DRUG

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

Anaprazole Sodium + Rabeprazole Placebo

Anaprazole Sodium Placebo DRUG

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

Rabeprazole +Anaprazole Sodium Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years, male and female
• Has endoscopic diagnosis of active duodenal ulcer(s) (A1 or A2 stage) within 7 days prior to randomization
• or 2 ulcers, 3-15 mm in diameter.
• Signed informed concent form

You may not qualify if:

• 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 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；
• 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) or free triiodothyronine (FT3) and free thyroxin ( FT4) : \> upper limit of normal (ULN)；
• 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)；

Sponsors & Collaborators

• Sihuan Pharmaceutical Holdings Group Ltd.: lead

Related Publications (2)

• Ni H, Shi J, Hu M, Zhou N, Yang S. Cost-effectiveness analysis of Anaprazole versus Ilaprazole for the treatment of duodenal ulcers in China. Front Pharmacol. 2024 Jun 7;15:1407435. doi: 10.3389/fphar.2024.1407435. eCollection 2024.

  PMID: 38910891 DERIVED

• Zhu H, Pan X, Zhang L, Sun H, Fan H, Pan Z, Huang C, Shi Z, Ding J, Wang Q, Du Y, Lyu N, Li Z. Effect and safety of anaprazole in the treatment of duodenal ulcers: a randomized, rabeprazole-controlled, phase III non-inferiority study. Chin Med J (Engl). 2022 Dec 20;135(24):2941-2949. doi: 10.1097/CM9.0000000000002508.

  PMID: 36580650 DERIVED

MeSH Terms

Interventions

Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 2, 2020
• Study Start: January 20, 2020
• Primary Completion: February 15, 2021
• Study Completion: February 28, 2021
• Last Updated: January 2, 2020

Record last verified: 2019-11