Efficacy and Safety of Ilaprazole Based Bismuth-containin... | NCT02835560

Studies
Efficacy and Safety of Ilaprazole Based Bismuth-containing Quadruple Regimen for the First-line Treatment of Helicobacter Pylori Infection

NCT02835560

Sponsor

Livzon Pharmaceutical Group Inc.

Status

Completed

Last Update Posted

Jul 18, 2016Estimated

Enrollment

100Actual

Phase

Phase 4

Conditions

Helicobacter Pylori Eradication Antibiotic

Interventions

Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapy
Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jul 2015Actual

Completion Date

Not provided

First Submitted Date

Jul 9, 2016

First Submission Date that Met QC Criteria

Jul 15, 2016

First Posted Date

Jul 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2016

Last Update Posted Date

Jul 18, 2016Estimated

Name	Class
Fifth Affiliated Hospital, Sun Yat-Sen University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study compared efficacy and safety of Ilaprazole based bismuth-containing quadruple regimen therapy including Ilaprazole 5mg, Bismuth Potassium Citrate 220mg, Clarithromycin 500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori.

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 14 days, participants treated as Esoprazole based bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg, Bismuth Potassium Citrate 220mg, 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.

Detailed Description

This study compared efficacy and safety of Ilaprazole based bismuth-containing quadruple regimen therapy including Ilaprazole 5mg, Bismuth Potassium Citrate 220mg，Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori.

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 14 days, Participants treated as Esoprazole based bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg, Bismuth Potassium Citrate 220mg，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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	Ilaprazole-based quadruple therapy for 14 days: Ilaprazole 5mg bid	Drug: Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapy
Active Comparator	Active Comparator	Esoprazole Esoprazole-based quadruple therapy for 14 days: Esoprazole 20mg bid	Drug: Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapy	Drug	Ilaprazole -based quadruple therapy for 14 days: Ilaprazole 5mg bid, Bismuth Potassium Citrate 220mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid

Measure	Description	Time Frame
Eradication rate of Helicobacter pylori as assessed by UBT test		up to 2 months

Eligibility Module

Eligibility Criteria

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, Amoxicillin and Levofloxacin.
Subjects who are taking contraindicated medications for experimental and concomitant drug.
Patients with abnormal levels in the laboratory tests.
Total Bilirubin, Creatinine> 1.5 times upper limit of normal.
AST, ALT, Alkaline phosphatase, BUN> 2 times upper limit of normal.
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.