Efficacy and Safety of Ilaprazole Based Bismuth-containing Quadruple Regimen for the First-line Treatment of Helicobacter Pylori Infection

NCT ID: NCT02835560

Last Updated: 2016-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30

Brief Summary

This study compared efficacy and safety of Ilaprazole based bismuth-containing quadruple regimen therapy including Ilaprazole 5mg, Bismuth Potassium Citrate 220mg, Clarithromycin 500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori.

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 14 days, participants treated as Esoprazole based bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg, Bismuth Potassium Citrate 220mg, 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.

Detailed Description

This study compared efficacy and safety of Ilaprazole based bismuth-containing quadruple regimen therapy including Ilaprazole 5mg, Bismuth Potassium Citrate 220mg，Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori.

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 14 days, Participants treated as Esoprazole based bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg, Bismuth Potassium Citrate 220mg，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.

Conditions

Helicobacter Pylori Eradication Antibiotic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Ilaprazole-based quadruple therapy for 14 days: Ilaprazole 5mg bid

Group Type: EXPERIMENTAL

Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapy

Intervention Type: DRUG

Ilaprazole -based quadruple therapy for 14 days: Ilaprazole 5mg bid, Bismuth Potassium Citrate 220mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid

Active Comparator

Esoprazole

Esoprazole-based quadruple therapy for 14 days: Esoprazole 20mg bid

Group Type: ACTIVE_COMPARATOR

Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapy

Intervention Type: DRUG

Esoprazole -based quadruple therapy for 14 days: Esoprazole 20mg bid, Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid

Interventions

Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapy

Ilaprazole -based quadruple therapy for 14 days: Ilaprazole 5mg bid, Bismuth Potassium Citrate 220mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid

Intervention Type: DRUG

Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapy

Esoprazole -based quadruple therapy for 14 days: Esoprazole 20mg bid, Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid

Intervention Type: DRUG

Eligibility Criteria

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, Amoxicillin and Levofloxacin.
• Subjects who are taking contraindicated medications for experimental and concomitant drug.
• Patients with abnormal levels in the laboratory tests.
• Total Bilirubin, Creatinine> 1.5 times upper limit of normal.
• AST, ALT, Alkaline phosphatase, BUN> 2 times upper limit of normal.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Livzon Pharmaceutical Group Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Livzon-IY-81149R

Identifier Type: -

Identifier Source: org_study_id