NCT00687336

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
178

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

July 8, 2009

Status Verified

July 1, 2009

Enrollment Period

2.2 years

First QC Date

May 27, 2008

Last Update Submit

July 7, 2009

Conditions

Peptic Ulcer Hemorrhage

Keywords

Helicobacter pyloriTreatmentUpper gastrointestinal bleeding

Outcome Measures

Primary Outcomes (1)

  • Helicobacter pylori eradication rate

    two years

Secondary Outcomes (1)

  • Economical evaluation through cost-effectivity study of the empiric erradicator Helicobacter pylori treatment.

    two years

Study Arms (2)

1

ACTIVE COMPARATOR

Empirical eradication treatment

Other: Empirical Hp eradication

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

Interventions

Empirical Hp eradicationOTHER

Empirical Helicobacter pylori treatment initiated immediately after oral intake is resumed

Also known as: Standard Hp eradication treatment
1
Eradication treatment guided by a positive testOTHER

Eradication treatment given if there is at least one positive diagnostic test (URT, histological test, breath test or serology) for Helicobacter pylori.

Also known as: Standard Hp treatment
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Previous eradication treatment.
  • Need for Antisecretor treatment that cannot be stopped to perform the breath test.
  • Pregnancy or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Sabadell, Institut Universitari Parc Tauli

Sabadell, Barcelona, 08208, Spain

RECRUITING

Related Publications (22)

  • 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.

    PMID: 7982436BACKGROUND

  • Lambert JR, Lin SK, Aranda-Michel J. Helicobacter pylori. Scand J Gastroenterol Suppl. 1995;208:33-46. doi: 10.3109/00365529509107760.

    PMID: 7777803BACKGROUND

  • 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.

    PMID: 15887152BACKGROUND

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

    PMID: 8547530BACKGROUND

  • 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.

    PMID: 10091208BACKGROUND

  • 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.

    PMID: 10573377BACKGROUND

  • 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.

    PMID: 1987878BACKGROUND

  • 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.

    PMID: 8058080BACKGROUND

  • 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.

    PMID: 2890019BACKGROUND

  • 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.

    PMID: 2904568BACKGROUND

  • 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.

    PMID: 8284627BACKGROUND

  • 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.

    PMID: 7698617BACKGROUND

  • 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.

    PMID: 9647020BACKGROUND

  • 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.

    PMID: 15230669BACKGROUND

  • 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.

    PMID: 16494583BACKGROUND

  • 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.

    PMID: 16159556BACKGROUND

  • 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.

    PMID: 16393280BACKGROUND

  • 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.

    PMID: 11121912BACKGROUND

  • 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.

    PMID: 9440631BACKGROUND

  • 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.

    PMID: 11444470BACKGROUND

  • 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.

    PMID: 6145023BACKGROUND

  • 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.

    PMID: 11246348BACKGROUND

MeSH Terms

Conditions

Peptic Ulcer HemorrhageGastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pilar Garcia, Dra.

    Hospital de Sabadell

    PRINCIPAL INVESTIGATOR

  • Xavier Calvet, Dr.

    Hospital de Sabadell

    STUDY CHAIR

Central Study Contacts

Pilar Garcia, Dra.

CONTACT

34-93-723-1010pgarciai@telefonica.net

Xavier Calvet, Dr.

CONTACT

34-93-723-1010xcalvet@tauli.cat

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 30, 2008

Study Start

March 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

July 8, 2009

Record last verified: 2009-07

Locations

ES(1)