Helicobacter Pylori Eradication Treatment in Patients Wit... | NCT01199536

Studies
Helicobacter Pylori Eradication Treatment in Patients With Duodenal Ulcers

NCT01199536

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Nov 25, 2013Estimated

Enrollment

59Actual

Phase

Not provided

Conditions

Duodenal Ulcer

Interventions

Not provided

Countries

Russia

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

Nov 2013

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

Nov 2010

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Sep 9, 2010

First Submission Date that Met QC Criteria

Sep 10, 2010

First Posted Date

Sep 13, 2010Estimated

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

Nov 22, 2013

Last Update Posted Date

Nov 25, 2013Estimated

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

The Study purpose is to evaluate Helicobacter pylori susceptibility to Clarithromycin and to estimate eradication and healing rates of duodenal ulcer routine eradication therapy at the end of treatment and 52 weeks from the therapy start

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

59Actual

Label	Type	Description	Intervention Names
1		patients with Helicobacter-positive duodenal ulcer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Eradication rate of H. pylori at the end routine triple eradication therapy		1 year

Secondary Outcomes

Measure	Description	Time Frame
Recurrence rate of duodenal ulcer (in patients with ulcer defects in inclusion stage)		2 years
Frequency of duodenal ulcer relapses	Frequency of duodenal ulcer relapses based on gastroscopy data and recurrence rate of H.Pylori infection based on breath test data after 52 weeks from the start of the therapy.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Active duodenal ulcer with duodenal ulcer exacerbation confirmed by endoscopic signs of duodenal ulcer disease (acute ulcer or scar deformity of the duodenal bulb) and anamnesis data.
Helicobacter pylori positive diagnosis at entry by 13C-Urea Breath Test (UBT)
Prescription of the standard 7-day eradication therapy including esomeprazole 20 mg bd, amoxicillin 1000 mg bd, clarithromycin 500 mg bd
Written informed consent provided prior the start of participation in the study.

Exclusion Criteria:

Subjects who are unwilling or unable to provide informed consent
Current complication of duodenal ulcer disease, e.g. perforation, bleeding or pyloric stenosis
History of esophageal/gastric/duodenal surgery except of the patients underwent perforated ulcer closure or endoscopic hemostasis more than 6 months ago
Contraindications to Esomeprazole, Amoxicillin or Clarythromycin including known or suspected hypersensitivity or allergy
Treatment with Amoxicillin, Clarythromycin or Bismuth containing drugs one month prior to inclusion
Two or more previous attempts to eradicate H. Pylori

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

Hospital patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vladimir T. Ivashkin	Head of Chair of Internal Diseases Propedeutics and Gastroenterology at MMA n/a I.M. Sechenov	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Moscow			Russia

Condition Browse Module

MeSH Terms

ID	Term
D004381	Duodenal Ulcer

Ancestor Terms

ID	Term
D010437	Peptic Ulcer
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Blood samples for Hematology (whole blood) and Chemistry (serum), gasric mucosa biopsies taken during esophagogastroduodenoscopy (EGDS) in routine practice of Moscow Medical Academy n/a I.M. Sechenov, Moscow State Medical and Stomatological University, Central Clinical Hospital of Presidential Administration