A Phase 2 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers.

NCT04503629 | Completed Phase 2 DMC

• 1 other identifier: 3571-DU-2001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Duodenal Ulcer，DU

Outcome Measures

Primary Outcomes (1)

• The endoscopic healing rate of duodenal ulcers at week 4.

  The endoscopic ulcer healing rate is defined as the percentage of patients with endoscopic ulcer healed evaluated by investigators.

  Treatment of 4 weeks

Study Arms (3)

Anaprazole Sodium 20mg QD

EXPERIMENTAL

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

Drug: Anaprazole Sodium

Anaprazole Sodium 40mg QD

EXPERIMENTAL

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

Drug: Anaprazole Sodium

Rabeprazole sodium 10mg QD

ACTIVE COMPARATOR

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

Drug: Rabeprazole sodium

Interventions

Anaprazole Sodium DRUG

Anaprazole Sodium 20mg

Anaprazole Sodium 20mg QD

Rabeprazole sodium DRUG

Rabeprazole sodium 10mg

Rabeprazole sodium 10mg QD

Eligibility Criteria

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

You may qualify if:

• Age ≥18 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 other gastrointestinal disease (e.g.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)；
• 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

Study Sites (1)

The Fisrst Affiliated Hospital of NanChang University

Nanchang, Jiangxi, 330006, China

Location

Related Publications (1)

• Shu X, Zhu Z, Fu Y, Zhang Z, Wang J, Li X, He S, Fan H, Liu S, Zhang G, Tang J, Huang C, Du Q, Wang X, Xu B, Du Y, Chen Q, Wang B, Chen Y, Duan X, Xie Y, Huo L, Hou X, Lu N. 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. Front Med (Lausanne). 2021 Jul 14;8:690995. doi: 10.3389/fmed.2021.690995. eCollection 2021.

  PMID: 34336894 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 2
• 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: August 5, 2020
• First Posted: August 7, 2020
• Study Start: October 9, 2018
• Primary Completion: May 17, 2019
• Study Completion: May 17, 2019
• Last Updated: August 7, 2020

Record last verified: 2020-08

Locations

CN (1)