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Helicobacter Pylori Empiric Treatment in Ulcer Bleeding (HETUB)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Hospital de Sabadell.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Corporacion Parc Tauli
Centro de Investigación Biomédica en Red
Information provided by:
Hospital de Sabadell
ClinicalTrials.gov Identifier:
NCT00687336
First received: May 27, 2008
Last updated: July 7, 2009
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Peptic Ulcer Hemorrhage
 Other: Empirical Hp eradication
Other: Eradication treatment guided by a positive test
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Study Comparing Helicobacter Pylori Empiric Eradication With Test-Guided Treatment in Patients With Peptic Ulcer Bleeding

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital de Sabadell:

Primary Outcome Measures:
  • Helicobacter pylori eradication rate [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Economical evaluation through cost-effectivity study of the empiric erradicator Helicobacter pylori treatment. [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 178
Study Start Date: March 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Empirical eradication treatment
 Other: Empirical Hp eradication
Empirical Helicobacter pylori treatment initiated immediately after oral intake is resumed
Other Name: 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 Name: Standard Hp treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687336

Contacts
Contact: Pilar Garcia, Dra. 34-93-723-1010 ext 20101 pgarciai@telefonica.net
Contact: Xavier Calvet, Dr. 34-93-723-1010 ext 20101 xcalvet@tauli.cat

Locations
Spain
Hospital de Sabadell, Institut Universitari Parc Tauli Recruiting
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Hospital de Sabadell
Corporacion Parc Tauli
Centro de Investigación Biomédica en Red
Investigators
Principal Investigator: Pilar Garcia, Dra. Hospital de Sabadell
Study Chair: Xavier Calvet, Dr. Hospital de Sabadell
  More Information

Publications:

Responsible Party: Dr. Xavier Calvet Calvo, Hospital de Sabadell
ClinicalTrials.gov Identifier: NCT00687336     History of Changes
Other Study ID Numbers: CIR2007/058
Study First Received: May 27, 2008
Last Updated: July 7, 2009
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital de Sabadell:
Helicobacter pylori
Treatment
Upper gastrointestinal bleeding

Additional relevant MeSH terms:
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Ulcer
Pathologic Processes
Duodenal Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage

ClinicalTrials.gov processed this record on June 18, 2013