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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Eradication Antibiotic
• Intervention / Treatment: Drug: Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapy; Drug: Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Ilaprazole-based quadruple therapy for 14 days: Ilaprazole 5mg bid	Drug: 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
Active Comparator: Active Comparator; Esoprazole Esoprazole-based quadruple therapy for 14 days: Esoprazole 20mg bid	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Eradication rate of Helicobacter pylori as assessed by UBT test	up to 2 months

Collaborators and Investigators

• Sponsor: Livzon Pharmaceutical Group Inc.
• Collaborators: Fifth Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: July 9, 2016
• First Submitted That Met QC Criteria: July 15, 2016
• First Posted (Estimate): July 18, 2016

Study Record Updates

• Last Update Posted (Estimate): July 18, 2016
• Last Update Submitted That Met QC Criteria: July 15, 2016
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: Livzon-IY-81149R