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

NCT02873065 | Completed Phase 4

• 1 other identifier: LivzonIY-81149R-11-02
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Helicobacter Pylori Eradication

Outcome Measures

Primary Outcomes (1)

• Eradication rate of Helicobacter pylori as assessed by UBT test

  4 weeks

Secondary Outcomes (1)

• Frequency of side effects of each treatment

  2 months

Study Arms (2)

Ilaprazole

EXPERIMENTAL

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

Drug: Ilaprazole

Esoprazole

ACTIVE COMPARATOR

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

Drug: Esoprazole

Interventions

Ilaprazole DRUG

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

Ilaprazole

Esoprazole DRUG

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

Esoprazole

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Livzon Pharmaceutical Group Inc.: lead

MeSH Terms

Interventions

ilaprazole; Amoxicillin; BID protein, human; Clarithromycin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 19, 2016
• Study Start: September 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 19, 2016

Record last verified: 2016-07