Bismuth Improves the Efficacy of Levofloxacin-containing... | NCT01667718

Studies
Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment

NCT01667718

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Completed

Last Update Posted

Dec 13, 2012Estimated

Enrollment

161Actual

Phase

Phase 4

Conditions

Functional Dyspepsia
Peptic Ulcer

Interventions

Bismuth
Lansoprazole
Levoﬂoxacin
Amoxicillin

Countries

China

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 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

May 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Jun 5, 2012

First Submission Date that Met QC Criteria

Aug 16, 2012

First Posted Date

Aug 17, 2012Estimated

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 12, 2012

Last Update Posted Date

Dec 13, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. HONG LU, Professor of GI Division, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and without Bismuth for H.pylori treatment.

Detailed Description

The success rate of the standard triple therapy for H. pylori infection is decreasing recently.Fluoroquinolone has been proposed to replace clarithromycin as an alternative in the treatment. However prevalence of H.pylori resistance to Levofloxacin has increased rapidly in our area. The purpose of this study is to observe the efficacy of 14 day Levofloxacin triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.

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

161Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Levofloxacin-triple therapy	Active Comparator	Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin	Drug: Lansoprazole Drug: Levoﬂoxacin Drug: Amoxicillin
Levofloxacin-quadruple therapy	Experimental	Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin	Drug: Bismuth Drug: Lansoprazole Drug: Levoﬂoxacin Drug: Amoxicillin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bismuth	Drug	Bismuth 220mg b.i.d for 2 weeks	Levofloxacin-quadruple therapy

Measure	Description	Time Frame
eradication rate of Helicobacter pylori		2 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who presented with upper gastrointestinal symptoms and endoscopically proven H.pylori-positive functional dyspepsia and scarred peptic ulcer

Exclusion Criteria:

patients with peptic ulcer, previous H.pylori eradication therapy, previous gastric surgery, pregnancy, lactation, major systemic diseases, receipt of anti-secretory therapy, antibiotics or bismuth in the preceding 4 weeks, or allergy to any one of the medications

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hong Lu	Shanghai Jiao-Tong University School of Medicine Renji Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Jiao-Tong University School of Medicine Renji Hospital		Shanghai	Shanghai Municipality	200127	China

Condition Browse Module

MeSH Terms

ID	Term
D010437	Peptic Ulcer

Ancestor Terms

ID	Term
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001729	Bismuth
D064747	Lansoprazole
D054328	Proton Pump Inhibitors
D000658	Amoxicillin

Ancestor Terms

ID	Term
D004603	Elements, Radioactive
D004602	Elements
D007287	Inorganic Chemicals
D019216	Metals, Heavy

Browse Leaves

Not provided

Browse Branches

Not provided