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

Sponsor

Livzon Pharmaceutical Group Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02873065

Collaborator

(none)

Arms

Duration (Months)

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Jun 1, 2015

Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ilaprazole Ilaprazole -based quadruple therapy for 7days：Ilaprazole -based quadruple therapy for 7days: Ilaprazole 5mg bid.	Drug: Ilaprazole Other Names: Ilaprazole and amoxicillin 1000mg bid, clarithromycin 500mg bid
Active Comparator: Esoprazole Esoprazole -based quadruple therapy for 14 days: Esoprazole 20mg bid.	Drug: Esoprazole Other Names: Esoprazole and Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid

Arm

Intervention/Treatment

Experimental: Ilaprazole

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

Drug: Ilaprazole

Other Names:

Ilaprazole and amoxicillin 1000mg bid, clarithromycin 500mg bid

Active Comparator: Esoprazole

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

Drug: Esoprazole

Other Names:

Esoprazole and Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid

Outcome Measures

Primary Outcome Measures

Eradication rate of Helicobacter pylori as assessed by UBT test [4 weeks]

Secondary Outcome Measures

Frequency of side effects of each treatment [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Livzon Pharmaceutical Group Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Livzon Pharmaceutical Group Inc.

ClinicalTrials.gov Identifier:

NCT02873065

Other Study ID Numbers:

LivzonIY-81149R-11-02

First Posted:

Aug 19, 2016

Last Update Posted:

Aug 19, 2016

Last Verified:

Jul 1, 2016

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2016