Efficacy and Safety of 1-week Triple Therapy With Ilaprazole for the Eradication of Helicobacter Pylori

Phase 4

Completed

• Conditions: Helicobacter Pylori Eradication
• Interventions: Drug: Esoprazole; Drug: Ilaprazole

• Registration Number: NCT02873065
• Lead Sponsor: Livzon Pharmaceutical Group Inc.

Brief Summary

This study compared efficacy and safety of Ilaprazole based triple regimen therapy including Ilaprazole 5mg, Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori

Detailed Description

Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) ,gastritis and dyspepsia confirmed to be H.pylori positive patients in the biopsy and UBT test. For 7 days, Participants treated as Esoprazole based triple regimen therapy therapy including Esoprazole 20mg，Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test and Biopsy at 49±5days from the first day dosing

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-07
• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-08-16
• Last Update Submitted: 2016-08-16
• Study First Posted: 2016-08-19
• Last Update Posted: 2016-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Subject must have endoscopically confirmed on gastric, duodenal ulcer(including scar) or gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test.
• Subject who fully understands conditions of clinical trial.
• Subject who agrees to participate and spontaneously sign the ICF

Exclusion Criteria

• Known hypersensitivity to any component of ilaprazole, Esoprazole, Amoxicillin and Clarithromycin
• Subjects who are taking contraindicated medications for experimental and concomitant drug
• Administrated of PPI, antibiotic medication within 4 weeks prior to commencement of the study
• Pregnant and/or lactating women
• Reproductive aged women not using contraception
• Uncontrolled diabetics
• Uncontrolled hypertension
• Uncontrolled liver dysfunction
• Alcoholics
• Subjects with a history of digestive malignancy within 5 years
• Subjects with a history of gastrectomy or esophagectomy
• Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption
• Subjects participating in a clinical trial before another trial within 30 days
• Inconsistent judged subject by researcher

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esoprazole	Esoprazole	Esoprazole -based quadruple therapy for 14 days: Esoprazole 20mg bid.
Ilaprazole	Ilaprazole	Ilaprazole -based quadruple therapy for 7days：Ilaprazole -based quadruple therapy for 7days: Ilaprazole 5mg bid.

Primary Outcome Measures

Name	Time	Method
Eradication rate of Helicobacter pylori as assessed by UBT test	4 weeks

Secondary Outcome Measures

Name	Time	Method
Frequency of side effects of each treatment	2 months