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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02873065

Enrollment

Unknown

Registered

2016-08-19

Start date

2014-09-30

Completion date

2015-06-30

Last updated

2016-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Eradication

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

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

Interventions

DRUGIlaprazole

DRUGEsoprazole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Eradication rate of Helicobacter pylori as assessed by UBT test	4 weeks

Secondary

Measure	Time frame
Frequency of side effects of each treatment	2 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026