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Helicobacter Pylori Empiric Treatment in Ulcer Bleeding (HETUB)

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ClinicalTrials.gov Identifier: NCT00687336
Recruitment Status : Unknown
Verified July 2009 by Hospital de Sabadell.
Recruitment status was:  Recruiting
First Posted : May 30, 2008
Last Update Posted : July 8, 2009
Sponsor:
Collaborators:
Corporacion Parc Tauli
Consorcio Centro de Investigación Biomédica en Red, M.P.
Information provided by:
Hospital de Sabadell

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2008
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : May 2010

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Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. Helicobacter pylori eradication rate [ Time Frame: two years ]

Secondary Outcome Measures :
  1. Economical evaluation through cost-effectivity study of the empiric erradicator Helicobacter pylori treatment. [ Time Frame: two years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Consorcio Centro de Investigación Biomédica en Red, M.P.
Investigators
Principal Investigator: Pilar Garcia, Dra. Hospital de Sabadell
Study Chair: Xavier Calvet, Dr. Hospital de Sabadell
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: July 8, 2009
Last Verified: July 2009

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

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