Clarithromycin Triple Therapy Plus Bismuth for Helicobact... | NCT02732249

Studies
Clarithromycin Triple Therapy Plus Bismuth for Helicobacter Pylori First-line Treatment

NCT02732249

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Completed

Last Update Posted

Jun 26, 2018Actual

Enrollment

66Actual

Phase

Phase 4

Conditions

Helicobacter Pylori Infection

Interventions

Esomeprazole
Bismuth Potassium Citrate
Clarithromycin
Metronidazole

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

Jun 2018

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

Apr 1, 2016Actual

Primary Completion Date

Sep 30, 2017Actual

Completion Date

Sep 30, 2017Actual

First Submitted Date

Apr 4, 2016

First Submission Date that Met QC Criteria

Apr 4, 2016

First Posted Date

Apr 8, 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

Jun 24, 2018

Last Update Posted Date

Jun 26, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hong Lu, MD, Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital, 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

Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole are no longer recommended as empirical ﬁrst-line therapy to treat Helicobacter pylori infection because of high antibiotic resistance. It is unknown whether the addition of bismuth overcome antibiotic resistance. This study is designed to evaluate the efficacy and safety of the addition of bismuth to standard triple therapy for H. pylori first-line eradication.

Detailed Description

Not provided

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

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Triple regimen group	Active Comparator	Esomeprazole 20mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days	Drug: Esomeprazole Drug: Clarithromycin Drug: Metronidazole
Low metronidazole group	Experimental	Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg bid for 14 days	Drug: Esomeprazole Drug: Bismuth Potassium Citrate Drug: Clarithromycin Drug: Metronidazole
High metronidazole group	Experimental	Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days	Drug: Esomeprazole Drug: Bismuth Potassium Citrate Drug: Clarithromycin Drug: Metronidazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Esomeprazole	Drug	Given 30 min before morning and evening meals	High metronidazole group Low metronidazole group Triple regimen group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Helicobacter pylori eradication rate		Six weeks after completion of therapy

Secondary Outcomes

Measure	Description	Time Frame
Rate of adverse effects		within 7 days after completion of therapy
Compliance rate		within 7 days after completion of therapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease
Ability and willingness to participate in the study and to sign and give informed consent
confirmed H. pylori infection

Exclusion Criteria:

Previous H. pylori eradication therapy
Less than 18 years old
With history of H. pylori infection treatment
With previous gastric surgery
Major systemic diseases
Pregnancy or lactation
Allergy to any of the study drugs
Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

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, MD	Renji Hospital, School of Medicine, Shanghai Jiao Tong University.	Principal Investigator

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064098	Esomeprazole
D017291	Clarithromycin
D008795	Metronidazole

Ancestor Terms

ID	Term
D009853	Omeprazole
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds

Browse Leaves

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Browse Branches

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