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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peptic Ulcer Hemorrhage | Other: Empirical Hp eradication Other: Eradication treatment guided by a positive test | Phase 4 |
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 |
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).
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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
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- Helicobacter pylori eradication rate [ Time Frame: two years ]
- Economical evaluation through cost-effectivity study of the empiric erradicator Helicobacter pylori treatment. [ Time Frame: two years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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.
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.

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
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 | |
Hospital de Sabadell, Institut Universitari Parc Tauli | Recruiting |
Sabadell, Barcelona, Spain, 08208 |
Principal Investigator: | Pilar Garcia, Dra. | Hospital de Sabadell | |
Study Chair: | Xavier Calvet, Dr. | Hospital de Sabadell |
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 |