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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00687336
Acronym
HETUB
Enrollment
178
Registered
2008-05-30
Start date
2008-03-31
Completion date
2010-05-31
Last updated
2009-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peptic Ulcer Hemorrhage

Keywords

Helicobacter pylori, Treatment, Upper gastrointestinal bleeding

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.

Interventions

OTHEREmpirical Hp eradication

Empirical Helicobacter pylori treatment initiated immediately after oral intake is resumed

OTHEREradication 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.

Sponsors

Corporacion Parc Tauli
CollaboratorOTHER
Consorcio Centro de Investigación Biomédica en Red (CIBER)
CollaboratorOTHER_GOV
Hospital de Sabadell
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication ratetwo years

Secondary

MeasureTime frame
Economical evaluation through cost-effectivity study of the empiric erradicator Helicobacter pylori treatment.two years

Countries

Spain

Contacts

Primary ContactPilar Garcia, Dra.
pgarciai@telefonica.net34-93-723-1010
Backup ContactXavier Calvet, Dr.
xcalvet@tauli.cat34-93-723-1010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026