Clinical trial NCT00251979: A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer
Official title: A Randomised, Double-blind, Parallel-group, Placebo Controlled Study of Esomeprazole i.v. (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour) Administered for 72 Hours to Assess Prevention of Rebleeding in Subjects That Have Undergone Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer - the PUB Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastrointestinal Hemorrhage
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-11
Enrollment: 1312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.


Eligibility criteria: Inclusion Criteria:

* Signs of a bleeding in the stomach
* One endoscopically confirmed bleeding ulcer in the stomach or duodenum

Exclusion Criteria:

* Malignancy or other advanced disease.
* Major cardiovascular event.
* Severe hepatic disease

Primary outcomes:
measure: Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo
timeFrame: Within 72 hours
Secondary outcomes:
measure: Clinically Significant Rebleeding Within 7 Days
timeFrame: Within 7 days
measure: Clinically Significant Rebleeding Within 30 Days
timeFrame: Within 30 days
measure: Death Within 72 Hours
timeFrame: Within 72 hours
measure: Death Within 30 Days
timeFrame: Within 30 days
measure: Death Related to Rebleeding Within 30 Days as Judged by the EpC
timeFrame: Within 30 days
measure: Requirement for Surgery Within 72 Hours
timeFrame: Within 72 hours
measure: Requirement for Surgery Within 30 Days
timeFrame: Within 30 days
measure: Requirement for Endoscopic Re-treatment Within 72 Hours
timeFrame: Within 72 hours
measure: Requirement for Endoscopic Re-treatment Within 30 Days
timeFrame: Within 30 days
measure: Number of Blood Units Transfused Within 72 Hours
timeFrame: Within 72 hours
measure: Number of Blood Units Transfused Within 30 Days
timeFrame: within 30 days
measure: Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period
timeFrame: Within 30 days
Other outcomes:
Locations:
city: Braunau/Inn
country: Austria
facility: Research Site
city: Feldbach
country: Austria
facility: Research Site
city: Graz
country: Austria
facility: Research Site
city: Krems
country: Austria
facility: Research Site
city: Wels
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Aalborg
country: Denmark
facility: Research Site
city: Amager
country: Denmark
facility: Research Site
city: Glostrup
country: Denmark
facility: Research Site
city: Holstebro
country: Denmark
facility: Research Site
city: Kobenhavn
country: Denmark
facility: Research Site
city: Odense
country: Denmark
facility: Research Site
city: Randers
country: Denmark
facility: Research Site
city: Slagelse
country: Denmark
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Amiens
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Clermont-Ferrand CEDEX 1
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Nice Cedex 3
country: France
facility: Research Site
city: Paris Cedex 12
country: France
facility: Research Site
city: Paris Cedex 13
country: France
facility: Research Site
city: Rouen
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Celle
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Karlsruhe
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Ludwigshafen
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Weimar
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Arnhem
country: Netherlands
facility: Research Site
city: Dordrecht
country: Netherlands
facility: Research Site
city: Hengelo
country: Netherlands
facility: Research Site
city: Nieuwegein
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Zwolle
country: Netherlands
facility: Research Site
city: Alesund
country: Norway
facility: Research Site
city: Drammen
country: Norway
facility: Research Site
city: Kristiansand
country: Norway
facility: Research Site
city: Lorenskog
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Tonsberg
country: Norway
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Tg. Mures
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Bloemfontein
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Pietermaritzburg
country: South Africa
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Sabadell
country: Spain
facility: Research Site
city: Santiago
country: Spain
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Karlstad
country: Sweden
facility: Research Site
city: Kristianstad
country: Sweden
facility: Research Site
city: Linköping
country: Sweden
facility: Research Site
city: Norrkoping
country: Sweden
facility: Research Site
city: Ostersund
country: Sweden
facility: Research Site
city: Skövde
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Sundsvall
country: Sweden
facility: Research Site
city: Trollhättan
country: Sweden
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Bursa
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Izmit
country: Turkey
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Derby
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Nexium Medical Sciences Director
role: STUDY_DIRECTOR
affiliation: Chinese University of Hong Kong
name: Joseph Sung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lau J, Lind T, Persson T, Eklund S. Effect of baseline characteristics on response to proton pump inhibitors in patients with peptic ulcer bleeding. J Dig Dis. 2017 Feb;18(2):99-106. doi: 10.1111/1751-2980.12447.
citation: Kuipers EJ, Sung JJ, Barkun A, Mossner J, Jensen D, Stuart R, Lau JY, Ahlbom H, Lind T, Kilhamn J. Safety and tolerability of high-dose intravenous esomeprazole for prevention of peptic ulcer rebleeding. Adv Ther. 2011 Feb;28(2):150-9. doi: 10.1007/s12325-010-0095-5. Epub 2010 Dec 15.
citation: Barkun AN, Adam V, Sung JJ, Kuipers EJ, Mossner J, Jensen D, Stuart R, Lau JY, Naucler E, Kilhamn J, Granstedt H, Liljas B, Lind T. Cost effectiveness of high-dose intravenous esomeprazole for peptic ulcer bleeding. Pharmacoeconomics. 2010;28(3):217-30. doi: 10.2165/11531480-000000000-00000.
citation: Sung JJ, Barkun A, Kuipers EJ, Mossner J, Jensen DM, Stuart R, Lau JY, Ahlbom H, Kilhamn J, Lind T; Peptic Ulcer Bleed Study Group. Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):455-64. doi: 10.7326/0003-4819-150-7-200904070-00105. Epub 2009 Feb 16.