Helicobacter Pylori Empiric Treatment in Ulcer Bleeding (HETUB)

July 7, 2009 updated by: Hospital de Sabadell

Phase IV Study Comparing Helicobacter Pylori Empiric Eradication With Test-Guided Treatment in Patients With Peptic Ulcer Bleeding

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

178

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Xavier Calvet, Dr.
  • Phone Number: 20101 34-93-723-1010
  • Email: xcalvet@tauli.cat

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Hospital de Sabadell, Institut Universitari Parc Tauli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Empirical eradication treatment
Other: Empirical Hp eradication
Empirical Helicobacter pylori treatment initiated immediately after oral intake is resumed
Other Names:
  • Standard Hp eradication treatment
Active Comparator: 2
Eradication treatment according to a diagnostic test (URT, histological test, breath test or serology).
Other: Eradication treatment guided by a positive test
Eradication treatment given if there is at least one positive diagnostic test (URT, histological test, breath test or serology) for Helicobacter pylori.
Other Names:
  • Standard Hp treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Helicobacter pylori eradication rate
Time Frame: two years
two years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Sabadell

Collaborators

Corporacion Parc Tauli
Consorcio Centro de Investigación Biomédica en Red (CIBER)

Investigators

  • Principal Investigator: Pilar Garcia, Dra., Hospital de Sabadell
  • Study Chair: Xavier Calvet, Dr., Hospital de Sabadell

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Anticipated)

May 1, 2010

Study Completion (Anticipated)

May 1, 2010

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

May 29, 2008

First Posted (Estimate)

May 30, 2008

Study Record Updates

Last Update Posted (Estimate)

July 8, 2009

Last Update Submitted That Met QC Criteria

July 7, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIR2007/058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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