HETUB: Helicobacter Pylori Empiric Treatment in Ulcer Bleeding

Sponsor

Hospital de Sabadell (Other)

Overall Status

Unknown status

CT.gov ID

NCT00687336

Collaborator

Corporacion Parc Tauli (Other), Consorcio Centro de Investigación Biomédica en Red, M.P. (Other)

178

Enrollment

Location

Arms

Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2008

Anticipated Primary Completion Date :

May 1, 2010

Anticipated Study Completion Date :

May 1, 2010

Arms and Interventions

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 Names: 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 Names: Standard Hp treatment

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 Names:

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 Names:

Standard Hp treatment

Outcome Measures

Primary Outcome Measures

Helicobacter pylori eradication rate [two years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.