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

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ClinicalTrials.gov Identifier: NCT02835560
Recruitment Status : Completed
First Posted : July 18, 2016
Last Update Posted : July 18, 2016
Sponsor:
Collaborator:
Fifth Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Livzon Pharmaceutical Group Inc.

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.


Condition or disease Intervention/treatment Phase
Helicobacter Pylori Eradication Antibiotic 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 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ilaprazole Based Bismuth-containing Quadruple Regimen for the First-line Treatment of Helicobacter Pylori Infection
Study Start Date : June 2013
Actual Primary Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

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




Primary Outcome Measures :
  1. Eradication rate of Helicobacter pylori as assessed by UBT test [ Time Frame: up to 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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Responsible Party: Livzon Pharmaceutical Group Inc.
ClinicalTrials.gov Identifier: NCT02835560    
Other Study ID Numbers: Livzon-IY-81149R
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: June 2012
Additional relevant MeSH terms:
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Infection