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

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ClinicalTrials.gov Identifier: NCT02873065
Recruitment Status : Completed
First Posted : August 19, 2016
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Eradication Drug: Ilaprazole Drug: Esoprazole Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2014
Actual Primary Completion Date : June 2015
Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: Ilaprazole
Ilaprazole -based quadruple therapy for 7days:Ilaprazole -based quadruple therapy for 7days: Ilaprazole 5mg bid.
Drug: Ilaprazole
Other Name: Ilaprazole and amoxicillin 1000mg bid, clarithromycin 500mg bid

Active Comparator: Esoprazole
Esoprazole -based quadruple therapy for 14 days: Esoprazole 20mg bid.
Drug: Esoprazole
Other Name: Esoprazole and 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: 4 weeks ]

Secondary Outcome Measures :
  1. Frequency of side effects of each treatment [ Time Frame: 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, 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
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Responsible Party: Livzon Pharmaceutical Group Inc.
ClinicalTrials.gov Identifier: NCT02873065    
Other Study ID Numbers: LivzonIY-81149R-11-02
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Amoxicillin
Clarithromycin
Potassium Citrate
Bismuth
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antacids
Gastrointestinal Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Expectorants
Respiratory System Agents