Helicobacter Pylori Empiric Treatment in Ulcer Bleeding
NCT ID: NCT00687336
Last Updated: 2009-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
178 participants
INTERVENTIONAL
2008-03-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Empirical eradication treatment
Empirical Hp eradication
Empirical Helicobacter pylori treatment initiated immediately after oral intake is resumed
2
Eradication treatment according to a diagnostic test (URT, histological test, breath test or serology).
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.
Interventions
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Empirical Hp eradication
Empirical Helicobacter pylori treatment initiated immediately after oral intake is resumed
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Use of antibiotics 2 weeks prior to inclusion.
* Need for Antisecretor treatment that cannot be stopped to perform the breath test.
* Pregnancy or breastfeeding.
18 Years
ALL
No
Sponsors
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Corporacion Parc Tauli
OTHER
Consorcio Centro de Investigación Biomédica en Red (CIBER)
OTHER_GOV
Hospital de Sabadell
OTHER
Responsible Party
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Hospital de Sabadell
Principal Investigators
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Pilar Garcia, Dra.
Role: PRINCIPAL_INVESTIGATOR
Hospital de Sabadell
Xavier Calvet, Dr.
Role: STUDY_CHAIR
Hospital de Sabadell
Locations
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Hospital de Sabadell, Institut Universitari Parc Tauli
Sabadell, Barcelona, Spain
Countries
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Central Contacts
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References
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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.
Lambert JR, Lin SK, Aranda-Michel J. Helicobacter pylori. Scand J Gastroenterol Suppl. 1995;208:33-46. doi: 10.3109/00365529509107760.
Houghton 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.
Kuipers EJ, Thijs JC, Festen HP. The prevalence of Helicobacter pylori in peptic ulcer disease. Aliment Pharmacol Ther. 1995;9 Suppl 2:59-69.
Gisbert 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.
Gisbert 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.
Soll 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.
Laine L, Peterson WL. Bleeding peptic ulcer. N Engl J Med. 1994 Sep 15;331(11):717-27. doi: 10.1056/NEJM199409153311107. No abstract available.
Coghlan 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.
Marshall 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.
Graham 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.
Rokkas 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.
Macri 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.
Castro-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.
Gisbert 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.
Gisbert JP, Calvet X, Gomollon F, Mones J; Grupo Conferencia Espanola de Consenso sobre Helicobacter pylori. [Eradication treatment of Helicobacter pylori. Recommendations of the II Spanish Consensus Conference]. Med Clin (Barc). 2005 Sep 10;125(8):301-16. doi: 10.1157/13078424. No abstract available. Spanish.
Guell M, Artigau E, Esteve V, Sanchez-Delgado J, Junquera F, Calvet X. Usefulness of a delayed test for the diagnosis of Helicobacter pylori infection in bleeding peptic ulcer. Aliment Pharmacol Ther. 2006 Jan 1;23(1):53-9. doi: 10.1111/j.1365-2036.2006.02726.x.
Garcia-Altes A, Jovell AJ, Serra-Prat M, Aymerich M. Management of Helicobacter pylori in duodenal ulcer: a cost-effectiveness analysis. Aliment Pharmacol Ther. 2000 Dec;14(12):1631-8. doi: 10.1046/j.1365-2036.2000.00871.x.
Sung JJ, Leung WK, Suen R, Leung VK, Chan FK, Ling TK, Lau JY, Lee YT, Ng EK, Cheng AF, Chung SC. One-week antibiotics versus maintenance acid suppression therapy for Helicobacter pylori-associated peptic ulcer bleeding. Dig Dis Sci. 1997 Dec;42(12):2524-8. doi: 10.1023/a:1018816729449.
Gisbert JP, Gonzalez L, de Pedro A, Valbuena M, Prieto B, Llorca I, Briz R, Khorrami S, Garcia-Gravalos R, Pajares JM. Helicobacter pylori and bleeding duodenal ulcer: prevalence of the infection and role of non-steroidal anti-inflammatory drugs. Scand J Gastroenterol. 2001 Jul;36(7):717-24. doi: 10.1080/003655201300191978.
Marshall BJ, Warren JR. Unidentified curved bacilli in the stomach of patients with gastritis and peptic ulceration. Lancet. 1984 Jun 16;1(8390):1311-5. doi: 10.1016/s0140-6736(84)91816-6.
Pellicano R, Peyre S, Leone N, Repici A, De Angelis C, Rizzi R, Rizzetto M, Ponzetto A. The effect of the eradication of Helicobacter pylori infection on hemorrhage because of duodenal ulcer. J Clin Gastroenterol. 2001 Mar;32(3):222-4. doi: 10.1097/00004836-200103000-00008.
Other Identifiers
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CIR2007/058
Identifier Type: -
Identifier Source: org_study_id
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