Helicobacter Pylori Empiric Treatment in Ulcer Bleeding | NCT00687336

Studies
Helicobacter Pylori Empiric Treatment in Ulcer Bleeding

NCT00687336

Sponsor

Hospital de Sabadell

Status

Unknown status

Last Update Posted

Jul 8, 2009Estimated

Enrollment

178Estimated

Phase

Phase 4

Conditions

Peptic Ulcer Hemorrhage

Interventions

Empirical Hp eradication
Eradication treatment guided by a positive test

Countries

Spain

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

Jul 2009

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

Mar 2008

Primary Completion Date

May 2010Estimated

Completion Date

May 2010Estimated

First Submitted Date

May 27, 2008

First Submission Date that Met QC Criteria

May 29, 2008

First Posted Date

May 30, 2008Estimated

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 7, 2009

Last Update Posted Date

Jul 8, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Hospital de SabadellOTHER

Collaborators

Name	Class
Corporacion Parc Tauli	OTHER
Consorcio Centro de Investigación Biomédica en Red (CIBER)	OTHER_GOV

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 goal of the study is to compare the effectiveness of empirical Helicobacter pylori treatment compared with treatment depending on diagnostic tests for Helicobacter pylori in patients with Upper gastrointestinal bleeding due to peptic ulcer. Main hypothesis is that empirical treatment will reduce the number of patients lost to follow-up thus improving the cure rates of Hp infection.

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

178Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Empirical eradication treatment	Other: Empirical Hp eradication
2	Active Comparator	Eradication treatment according to a diagnostic test (URT, histological test, breath test or serology).	Other: Eradication treatment guided by a positive test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Empirical Hp eradication	Other	Empirical Helicobacter pylori treatment initiated immediately after oral intake is resumed	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Helicobacter pylori eradication rate		two years

Secondary Outcomes

Measure	Description	Time Frame
Economical evaluation through cost-effectivity study of the empiric erradicator Helicobacter pylori treatment.		two years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients older than 18.
Informed Consent signed.
Diagnosis of no variceal upper gastrointestinal bleeding secondary to a duodenal ulcer, erosive duodenitis or gastric ulcer.
Life expectancy longer than 6 months.
Able to attend further clinical controls.
Absence of the following exclusion criteria.

Exclusion Criteria:

Previous eradication treatment.
Use of antibiotics 2 weeks prior to inclusion.
Need for Antisecretor treatment that cannot be stopped to perform the breath test.
Pregnancy or breastfeeding.

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

Name	Role	Phone	Extension	Email
Pilar Garcia, Dra.	Contact	34-93-723-1010	20101	pgarciai@telefonica.net
Xavier Calvet, Dr.	Contact	34-93-723-1010	20101	xcalvet@tauli.cat

Overall Officials

Name	Affiliation	Role
Pilar Garcia, Dra.	Hospital de Sabadell	Principal Investigator
Xavier Calvet, Dr.	Hospital de Sabadell	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Sabadell, Institut Universitari Parc Tauli	Recruiting	Sabadell	Barcelona	08208	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7982436	Background	Calam J. Helicobacter pylori. Eur J Clin Invest. 1994 Aug;24(8):501-10. doi: 10.1111/j.1365-2362.1994.tb01099.x. No abstract available.
7777803	Background	Lambert JR, Lin SK, Aranda-Michel J. Helicobacter pylori. Scand J Gastroenterol Suppl. 1995;208:33-46. doi: 10.3109/00365529509107760.

ID	Term
D010438	Peptic Ulcer Hemorrhage
D006471	Gastrointestinal Hemorrhage

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006470	Hemorrhage
D010335	Pathologic Processes