Helicobacter Pylori Empiric Treatment in Ulcer Bleeding - Full Text View

Sponsors and Collaborators:	Hospital de Sabadell Corporacion Parc Tauli CIBEREHD
Information provided by:	Hospital de Sabadell
ClinicalTrials.gov Identifier:	NCT00687336

Purpose

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	Intervention	Phase
Peptic Ulcer Hemorrhage	Other: Empirical Hp eradication Other: Eradication treatment guided by a positive test	Phase IV

MedlinePlus related topics: Gastrointestinal Bleeding Peptic Ulcer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Phase IV Study Comparing Helicobacter Pylori Empiric Eradication With Test-Guided Treatment in Patients With Peptic Ulcer Bleeding

Further study details as provided by Hospital de Sabadell:

Primary Outcome Measures:

Helicobacter pylori eradication rate [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Economical evaluation through cost-effectivity study of the empiric erradicator Helicobacter pylori treatment. [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment:	178
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Empirical eradication treatment	Other: Empirical Hp eradication Empirical Helicobacter pylori treatment initiated immediately after oral intake is resumed
2: Active Comparator 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687336

Contacts

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

Locations

Spain, Barcelona
Hospital de Sabadell, Institut Universitari Parc Tauli	Recruiting
Sabadell, Barcelona, Spain, 08208

Sponsors and Collaborators

Hospital de Sabadell

Corporacion Parc Tauli

CIBEREHD

Investigators

Principal Investigator:	Pilar Garcia, Dra.	Hospital de Sabadell
Study Chair:	Xavier Calvet, Dr.	Hospital de Sabadell

More Information

Publications:

Calam J. Helicobacter pylori. Eur J Clin Invest. 1994 Aug;24(8):501-10. Review. No abstract available.

Lambert JR, Lin SK, Aranda-Michel J. Helicobacter pylori. Scand J Gastroenterol Suppl. 1995;208:33-46. Review.

Houghton J, Wang TC. Helicobacter pylori and gastric cancer: a new paradigm for inflammation-associated epithelial cancers. Gastroenterology. 2005 May;128(6):1567-78. Review.

Kuipers EJ, Thijs JC, Festen HP. The prevalence of Helicobacter pylori in peptic ulcer disease. Aliment Pharmacol Ther. 1995;9 Suppl 2:59-69. Review.

Gisbert JP, Boixeda D, Aller R, de la Serna C, Sanz E, Martín de Argila C, Abraira V, García 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, Fernández-Salazar L, Fernández-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.

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. Review.

Laine L, Peterson WL. Bleeding peptic ulcer. N Engl J Med. 1994 Sep 15;331(11):717-27. Review. 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.

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.

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.

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.

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.

Castro-Fernández M, Sánchez-Muñoz D, García-Díaz 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. 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. Epub 2006 Feb 22. Review.

Gisbert JP, Calvet X, Gomollón F, Monés J; Grupo Conferencia Española 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. Review. Spanish. No abstract available.

Güell M, Artigau E, Esteve V, Sánchez-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.

García-Altés 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.

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.

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.

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.

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.

Responsible Party:	Hospital de Sabadell ( Dr. Xavier Calvet Calvo )
Study ID Numbers:	CIR2007/058
Study First Received:	May 27, 2008
Last Updated:	May 29, 2008
ClinicalTrials.gov Identifier:	NCT00687336
Health Authority:	Spain: Ethics Committee

Keywords provided by Hospital de Sabadell:

Helicobacter pylori
Treatment
Upper gastrointestinal bleeding

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Peptic Ulcer Hemorrhage

Gastrointestinal Hemorrhage
Intestinal Diseases
Hemorrhage
Duodenal Diseases
Peptic Ulcer

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009