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

NCT02835560 | Completed Phase 4 DMC

• 1 other identifier: Livzon-IY-81149R
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Helicobacter Pylori Eradication Antibiotic

Outcome Measures

Primary Outcomes (1)

• Eradication rate of Helicobacter pylori as assessed by UBT test

  up to 2 months

Study Arms (2)

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

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

Interventions

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

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

Experimental

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

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

Active Comparator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2016
• First Posted: July 18, 2016
• Study Start: June 1, 2013
• Primary Completion: July 1, 2015
• Last Updated: July 18, 2016

Record last verified: 2012-06