Clinical trial NCT00687336: Helicobacter Pylori Empiric Treatment in Ulcer Bleeding
Official title: Phase IV Study Comparing Helicobacter Pylori Empiric Eradication With Test-Guided Treatment in Patients With Peptic Ulcer Bleeding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Peptic Ulcer Hemorrhage
Keywords: Helicobacter pylori
Treatment
Upper gastrointestinal bleeding
Lead sponsor: Hospital de Sabadell
Sponsor class: OTHER
Collaborators: name: Corporacion Parc Tauli
name: Consorcio Centro de Investigación Biomédica en Red (CIBER)
First posted: 2008-05-30
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: two years
Secondary outcomes:
measure: Economical evaluation through cost-effectivity study of the empiric erradicator Helicobacter pylori treatment.
timeFrame: two years
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital de Sabadell, Institut Universitari Parc Tauli
state: Barcelona
Study officials:
affiliation: Hospital de Sabadell
name: Pilar Garcia, Dra.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Sabadell
name: Xavier Calvet, Dr.
role: STUDY_CHAIR
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