Prospective Study : Helicobacter Pylori Eradication Thera... | NCT01938534

Studies
Prospective Study : Helicobacter Pylori Eradication Therapy in Accordance With Past Antibiotics Use

NCT01938534

Sponsor

Ajou University School of Medicine

Status

Unknown status

Last Update Posted

Jan 1, 2014Estimated

Enrollment

440Estimated

Phase

Phase 4

Conditions

Helicobacter Eradication

Interventions

Helicobacter pylori eradication

Countries

South Korea

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Dec 2014Estimated

Completion Date

Not provided

First Submitted Date

Sep 5, 2013

First Submission Date that Met QC Criteria

Sep 9, 2013

First Posted Date

Sep 10, 2013Estimated

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

Dec 31, 2013

Last Update Posted Date

Jan 1, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sun Gyo Lim, Assistant professor, Ajou University School of MedicinePrincipal Investigator

Lead Sponsor

Ajou University School of MedicineOTHER

Collaborators

Not provided

Description Module

Brief Summary

Prospective study : Helicobacter pylori eradication therapy in accordance with past antibiotics use.

Detailed Description

Antibiotics resistant is serious problem in helicobacter pylori eradication. Clarithromycin is very important antibiotics in eradication. But clarithromycin resistance is increased. Major cause of clarithromycin resistance is past consumption of macrolide. Thus the investigators propose eradication of macrolide used group bismuth contained four drugs therapy.

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

440Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	Omeprazole 30mg twice Clarithromycin 500mg twice Amoxicillin 1000mg twice for 10 days	Drug: Helicobacter pylori eradication
Control	Active Comparator	Tetracycline 500mg four times Omeprazole 30mg twice Bismuth 600mg twice Metronidazole 500mg three times for 10 days	Drug: Helicobacter pylori eradication

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Helicobacter pylori eradication	Drug		Control Experimental

Measure	Description	Time Frame
Eradication rate of Helicobacter pylori		one month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Peptic ulcer disease
Gastric MALT lymphoma
Early gastric cancer
Familial history of gastric cancer
Idiopathic iron deficiency
Chronic idiopathic thrombocytopenia
Atrophic gastritis
Helicobacter infected dyspepsia
Long term NSAIDs use

Exclusion Criteria:

Pregnant
Previous proton pump inhibitor, antibiotics or anticoagulant use within 2 weeks
Previous stomach surgery
Severe ill patients (heart failure, hepatic failure, renal failure, hematologic disorder, severe psychologic or neurologic disorder)
Previous Helicobacter eradication
Allergy for Helicobacter eradication medicine

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

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ki Myung Lee, M.D., Ph.D.	Contact	82-31-219-6939		lkm5104@ajou.ac.kr
Sun Gyo Lim, M.D.	Contact	82-31-219-6939		mdlsk75@hanmail.net

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ajou University Hospital	Recruiting	Suwon		443-721	South Korea