Peptic Ulcer HemorrhagePhase 4HETUBNCT00687336
Helicobacter Pylori Empiric Treatment in Ulcer Bleeding
A Phase 4 study testing Empirical Hp eradication and Eradication treatment guided by a positive test in people with Peptic Ulcer Hemorrhage, run by Hospital de Sabadell at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer Hemorrhage
- What is being tested?
- Empirical Hp eradication and Eradication treatment guided by a positive test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2008to May 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Sabadell, Institut Universitari Parc Tauli
Sabadell, Barcelona, 08208
About this study
Official title: 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.
- Conditions
- Peptic Ulcer Hemorrhage
- Being tested
- Empirical Hp eradication, Eradication treatment guided by a positive test
- Keywords
- Helicobacter pylori, Treatment, Upper gastrointestinal bleeding
- Medical subject headings
- Peptic Ulcer Hemorrhage, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empirical Hp eradicationOther
Also called Standard Hp eradication treatment
Empirical Helicobacter pylori treatment initiated immediately after oral intake is resumed
Eradication treatment guided by a positive testOther
Also called Standard Hp treatment
Eradication treatment given if there is at least one positive diagnostic test (URT, histological test, breath test or serology) for Helicobacter pylori.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Empirical eradication treatment Receives: Other: Empirical Hp eradication |
| 2 | Active comparator | Eradication treatment according to a diagnostic test (URT, histological test, breath test or serology). Receives: Other: Eradication treatment guided by a positive test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication rate
Measured: two years
Secondary outcomes (1)
Economical evaluation through cost-effectivity study of the empiric erradicator Helicobacter pylori treatment.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2010 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Peptic Ulcer HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Sabadell
- Sponsor type
- University, hospital or other
- Collaborators
- Corporacion Parc Tauli, Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Investigators
- Pilar Garcia, Dra., Principal investigator, Hospital de SabadellXavier Calvet, Dr., Study chair, Hospital de Sabadell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687336
- Sponsor's protocol ID
- CIR2007/058
- Acronym
- HETUB
- Status last verified
- Jul 2009
- First submitted
- 27 May 2008
- Last updated
- 8 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Calam J. Helicobacter pylori. Eur J Clin Invest. 1994 Aug;24(8):501-10. doi: 10.1111/j.1365-2362.1994.tb01099.x. No abstract available.
PubMed 7982436Lambert JR, Lin SK, Aranda-Michel J. Helicobacter pylori. Scand J Gastroenterol Suppl. 1995;208:33-46. doi: 10.3109/00365529509107760.
PubMed 7777803Houghton J, Wang TC. Helicobacter pylori and gastric cancer: a new paradigm for inflammation-associated epithelial cancers. Gastroenterology. 2005 May;128(6):1567-78. doi: 10.1053/j.gastro.2005.03.037.
PubMed 15887152Kuipers EJ, Thijs JC, Festen HP. The prevalence of Helicobacter pylori in peptic ulcer disease. Aliment Pharmacol Ther. 1995;9 Suppl 2:59-69.
PubMed 8547530Gisbert JP, Boixeda D, Aller R, de la Serna C, Sanz E, Martin de Argila C, Abraira V, Garcia Plaza A. [Helicobacter pylori and digestive hemorrhage due to duodenal ulcer: the prevalence of the infection, the efficacy of 3 triple therapies and the role of eradication in preventing a hemorrhagic recurrence]. Med Clin (Barc). 1999 Feb 13;112(5):161-5. Spanish.
PubMed 10091208Gisbert JP, Blanco M, Mateos JM, Fernandez-Salazar L, Fernandez-Bermejo M, Cantero J, Pajares JM. H. pylori-negative duodenal ulcer prevalence and causes in 774 patients. Dig Dis Sci. 1999 Nov;44(11):2295-302. doi: 10.1023/a:1026669123593.
PubMed 10573377Soll AH, Weinstein WM, Kurata J, McCarthy D. Nonsteroidal anti-inflammatory drugs and peptic ulcer disease. Ann Intern Med. 1991 Feb 15;114(4):307-19. doi: 10.7326/0003-4819-114-4-307.
PubMed 1987878Laine L, Peterson WL. Bleeding peptic ulcer. N Engl J Med. 1994 Sep 15;331(11):717-27. doi: 10.1056/NEJM199409153311107. No abstract available.
PubMed 8058080Coghlan JG, Gilligan D, Humphries H, McKenna D, Dooley C, Sweeney E, Keane C, O'Morain C. Campylobacter pylori and recurrence of duodenal ulcers--a 12-month follow-up study. Lancet. 1987 Nov 14;2(8568):1109-11. doi: 10.1016/s0140-6736(87)91545-5.
PubMed 2890019Marshall BJ, Goodwin CS, Warren JR, Murray R, Blincow ED, Blackbourn SJ, Phillips M, Waters TE, Sanderson CR. Prospective double-blind trial of duodenal ulcer relapse after eradication of Campylobacter pylori. Lancet. 1988 Dec 24-31;2(8626-8627):1437-42. doi: 10.1016/s0140-6736(88)90929-4.
PubMed 2904568Graham DY, Hepps KS, Ramirez FC, Lew GM, Saeed ZA. Treatment of Helicobacter pylori reduces the rate of rebleeding in peptic ulcer disease. Scand J Gastroenterol. 1993 Nov;28(11):939-42. doi: 10.3109/00365529309098288.
PubMed 8284627Rokkas T, Karameris A, Mavrogeorgis A, Rallis E, Giannikos N. Eradication of Helicobacter pylori reduces the possibility of rebleeding in peptic ulcer disease. Gastrointest Endosc. 1995 Jan;41(1):1-4. doi: 10.1016/s0016-5107(95)70266-0.
PubMed 7698617Macri G, Milani S, Surrenti E, Passaleva MT, Salvadori G, Surrenti C. Eradication of Helicobacter pylori reduces the rate of duodenal ulcer rebleeding: a long-term follow-up study. Am J Gastroenterol. 1998 Jun;93(6):925-7. doi: 10.1111/j.1572-0241.1998.00278.x.
PubMed 9647020Castro-Fernandez M, Sanchez-Munoz D, Garcia-Diaz E, Miralles-Sanchiz J, Vargas-Romero J. Diagnosis of Helicobacter pylori infection in patients with bleeding ulcer disease: rapid urease test and histology. Rev Esp Enferm Dig. 2004 Jun;96(6):395-8; 398-401. doi: 10.4321/s1130-01082004000600005. English, Spanish.
PubMed 15230669Gisbert JP, Abraira V. Accuracy of Helicobacter pylori diagnostic tests in patients with bleeding peptic ulcer: a systematic review and meta-analysis. Am J Gastroenterol. 2006 Apr;101(4):848-63. doi: 10.1111/j.1572-0241.2006.00528.x. Epub 2006 Feb 22.
PubMed 16494583
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study Comparing Helicobacter Pylori Empiric Eradication With Test-Guided Treatment in Patients With Peptic Ulcer Bleeding
- ClinicalTrials.gov ID
- NCT00687336
- Acronym / sponsor ID
- HETUB / CIR2007/058
- Conditions
- Peptic Ulcer Hemorrhage
- Keywords
- Helicobacter pylori, Treatment, Upper gastrointestinal bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Hospital de SabadellUniversity, hospital or other
- Collaborators
- Corporacion Parc Tauli, Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Study start
- Mar 2008
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 30 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Empirical Hp eradicationEmpirical eradication treatment |
| 2 | Active comparator | Other: Eradication treatment guided by a positive testEradication treatment according to a diagnostic test (URT, histological test, breath test or serology). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empirical Hp eradicationAlso: Standard Hp eradication treatmentEmpirical Helicobacter pylori treatment initiated immediately after oral intake is resumed | Other | 1 |
| Eradication treatment guided by a positive testAlso: Standard Hp treatmentEradication treatment given if there is at least one positive diagnostic test (URT, histological test, breath test or serology) for Helicobacter pylori. | Other | 2 |
Primary outcome
Helicobacter pylori eradication rate
Time frame: two years
1 secondary outcome
Economical evaluation through cost-effectivity study of the empiric erradicator Helicobacter pylori treatment.
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2009.
- Background: PubMed 7982436Calam J. Helicobacter pylori. Eur J Clin Invest. 1994 Aug;24(8):501-10. doi: 10.1111/j.1365-2362.1994.tb01099.x. No abstract available.
- Background: PubMed 7777803Lambert JR, Lin SK, Aranda-Michel J. Helicobacter pylori. Scand J Gastroenterol Suppl. 1995;208:33-46. doi: 10.3109/00365529509107760.
- Background: PubMed 15887152Houghton J, Wang TC. Helicobacter pylori and gastric cancer: a new paradigm for inflammation-associated epithelial cancers. Gastroenterology. 2005 May;128(6):1567-78. doi: 10.1053/j.gastro.2005.03.037.
- Background: PubMed 8547530Kuipers EJ, Thijs JC, Festen HP. The prevalence of Helicobacter pylori in peptic ulcer disease. Aliment Pharmacol Ther. 1995;9 Suppl 2:59-69.
- Background: PubMed 10091208Gisbert JP, Boixeda D, Aller R, de la Serna C, Sanz E, Martin de Argila C, Abraira V, Garcia Plaza A. [Helicobacter pylori and digestive hemorrhage due to duodenal ulcer: the prevalence of the infection, the efficacy of 3 triple therapies and the role of eradication in preventing a hemorrhagic recurrence]. Med Clin (Barc). 1999 Feb 13;112(5):161-5. Spanish.
- Background: PubMed 10573377Gisbert JP, Blanco M, Mateos JM, Fernandez-Salazar L, Fernandez-Bermejo M, Cantero J, Pajares JM. H. pylori-negative duodenal ulcer prevalence and causes in 774 patients. Dig Dis Sci. 1999 Nov;44(11):2295-302. doi: 10.1023/a:1026669123593.
- Background: PubMed 1987878Soll AH, Weinstein WM, Kurata J, McCarthy D. Nonsteroidal anti-inflammatory drugs and peptic ulcer disease. Ann Intern Med. 1991 Feb 15;114(4):307-19. doi: 10.7326/0003-4819-114-4-307.
- Background: PubMed 8058080Laine L, Peterson WL. Bleeding peptic ulcer. N Engl J Med. 1994 Sep 15;331(11):717-27. doi: 10.1056/NEJM199409153311107. No abstract available.
- Background: PubMed 2890019Coghlan JG, Gilligan D, Humphries H, McKenna D, Dooley C, Sweeney E, Keane C, O'Morain C. Campylobacter pylori and recurrence of duodenal ulcers--a 12-month follow-up study. Lancet. 1987 Nov 14;2(8568):1109-11. doi: 10.1016/s0140-6736(87)91545-5.
- Background: PubMed 2904568Marshall BJ, Goodwin CS, Warren JR, Murray R, Blincow ED, Blackbourn SJ, Phillips M, Waters TE, Sanderson CR. Prospective double-blind trial of duodenal ulcer relapse after eradication of Campylobacter pylori. Lancet. 1988 Dec 24-31;2(8626-8627):1437-42. doi: 10.1016/s0140-6736(88)90929-4.
- Background: PubMed 8284627Graham DY, Hepps KS, Ramirez FC, Lew GM, Saeed ZA. Treatment of Helicobacter pylori reduces the rate of rebleeding in peptic ulcer disease. Scand J Gastroenterol. 1993 Nov;28(11):939-42. doi: 10.3109/00365529309098288.
- Background: PubMed 7698617Rokkas T, Karameris A, Mavrogeorgis A, Rallis E, Giannikos N. Eradication of Helicobacter pylori reduces the possibility of rebleeding in peptic ulcer disease. Gastrointest Endosc. 1995 Jan;41(1):1-4. doi: 10.1016/s0016-5107(95)70266-0.
Related trials for Peptic Ulcer Hemorrhage
RecruitingPhase 4
Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy
Coronary Artery Disease, Percutaneous Coronary Intervention
RecruitingPhase 2
Tegoprazan Versus Lansoprazole for Endoscopic Ulcer Healing in Bleeding Peptic Ulcers
Peptic Ulcer Bleeding
Not yet recruiting
Potassium-competitive Acid Blocker Versus Double Dose Proton Pump Inhibitors in High High-risk Peptic Ulcer Bleeding
Bleeding
Recruiting
Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment
Roux-en-y Anastomosis Site, Marginal Ulcer
Recruiting
Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding
Acute Gastrointestinal Bleeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pilar Garcia, Dra. principal investigator
Hospital de Sabadell
Xavier Calvet, Dr. study chair
Hospital de Sabadell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empirical Hp eradication and Eradication treatment guided by a positive test in people with Peptic Ulcer Hemorrhage, run by Hospital de Sabadell at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pilar Garcia, Dra. (34-93-723-1010 ext. 20101, pgarciai@telefonica.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori eradication rate (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00687336, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2009.