COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02873065
Recruitment Status : Completed
First Posted : August 19, 2016
Last Update Posted : August 19, 2016
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

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Layout table for additonal information
Responsible Party: Livzon Pharmaceutical Group Inc. 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:
Layout table for MeSH terms
Potassium Citrate
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
Gastrointestinal Agents
Natriuretic Agents
Physiological Effects of Drugs
Respiratory System Agents