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

May 27, 2008
July 7, 2009
March 2008
May 2010   (final data collection date for primary outcome measure)
Helicobacter pylori eradication rate [ Time Frame: two years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00687336 on ClinicalTrials.gov Archive Site
Economical evaluation through cost-effectivity study of the empiric erradicator Helicobacter pylori treatment. [ Time Frame: two years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Helicobacter Pylori Empiric Treatment in Ulcer Bleeding
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Peptic Ulcer Hemorrhage
  • Other: Empirical Hp eradication
    Empirical Helicobacter pylori treatment initiated immediately after oral intake is resumed
    Other Name: Standard Hp eradication treatment
  • 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
  • Active Comparator: 1
    Empirical eradication treatment
    Intervention: Other: Empirical Hp eradication
  • Active Comparator: 2
    Eradication treatment according to a diagnostic test (URT, histological test, breath test or serology).
    Intervention: Other: Eradication treatment guided by a positive test

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
178
May 2010
May 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
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
Spain
 
NCT00687336
CIR2007/058
No
Dr. Xavier Calvet Calvo, Hospital de Sabadell
Hospital de Sabadell
  • Corporacion Parc Tauli
  • Centro de Investigación Biomédica en Red
Principal Investigator: Pilar Garcia, Dra. Hospital de Sabadell
Study Chair: Xavier Calvet, Dr. Hospital de Sabadell
Hospital de Sabadell
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP