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CompletedNCT02873065Updated Aug 19, 2016

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

A Phase 4 interventional study of Ilaprazole and Esoprazole in Helicobacter Pylori Eradication, sponsored by Livzon Pharmaceutical Group Inc.. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-08-19.

Sponsored by Livzon Pharmaceutical Group Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Helicobacter Pylori Eradication
03

In context

Lead sponsor

Livzon Pharmaceutical Group Inc. is the lead sponsor of 28 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)

Study arms

  • Experimental
    Ilaprazole

    Ilaprazole -based quadruple therapy for 7days：Ilaprazole -based quadruple therapy for 7days: Ilaprazole 5mg bid.

    Drug: Ilaprazole

  • Active comparator
    Esoprazole

    Esoprazole -based quadruple therapy for 14 days: Esoprazole 20mg bid.

    Drug: Esoprazole

Interventions

  • DrugIlaprazole

    Also known as: Ilaprazole and amoxicillin 1000mg bid, clarithromycin 500mg bid

  • DrugEsoprazole

    Also known as: Esoprazole and Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid

06

What researchers measure

Primary outcomes

  1. Eradication rate of Helicobacter pylori as assessed by UBT test

    Time frame: 4 weeks

Secondary outcomes

  1. Frequency of side effects of each treatment

    Time frame: 2 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02873065
Lead sponsor
Livzon Pharmaceutical Group Inc.
Responsible party
Sponsor
First posted
Aug 19, 2016
Start date
Sep 2014
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Aug 19, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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