A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer

Gastrointestinal Hemorrhage Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251979
• Other study ID #: D961DC00001
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2005
• Last updated: May 18, 2011
• Start date: October 2005
• Est. completion date: December 2007

Study information

• Verified date: May 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1312
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage

Intervention

Drug:
• Esomeprazole

Locations

Country	Name	City	State
Austria	Research Site	Braunau/Inn
Austria	Research Site	Feldbach
Austria	Research Site	Graz
Austria	Research Site	Krems
Austria	Research Site	Wels
Austria	Research Site	Wien
Denmark	Research Site	Aalborg
Denmark	Research Site	Amager
Denmark	Research Site	Glostrup
Denmark	Research Site	Holstebro
Denmark	Research Site	Kobenhavn
Denmark	Research Site	Odense
Denmark	Research Site	Randers
Denmark	Research Site	Slagelse
Finland	Research Site	Helsinki
Finland	Research Site	Kuopio
France	Research Site	Amiens
France	Research Site	Bordeaux
France	Research Site	Clermont-Ferrand CEDEX 1
France	Research Site	Lille
France	Research Site	Nice Cedex 3
France	Research Site	Paris Cedex 12
France	Research Site	Paris Cedex 13
France	Research Site	Rouen
Germany	Research Site	Berlin
Germany	Research Site	Bochum
Germany	Research Site	Celle
Germany	Research Site	Dresden
Germany	Research Site	Karlsruhe
Germany	Research Site	Leipzig
Germany	Research Site	Ludwigshafen
Germany	Research Site	Magdeburg
Germany	Research Site	Weimar
Greece	Research Site	Athens
Greece	Research Site	Thessaloniki
Hong Kong	Research Site	Hong Kong
Netherlands	Research Site	Arnhem
Netherlands	Research Site	Dordrecht
Netherlands	Research Site	Hengelo
Netherlands	Research Site	Nieuwegein
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Zwolle
Norway	Research Site	Alesund
Norway	Research Site	Drammen
Norway	Research Site	Kristiansand
Norway	Research Site	Lorenskog
Norway	Research Site	Oslo
Norway	Research Site	Tonsberg
Romania	Research Site	Bucharest
Romania	Research Site	Craiova
Romania	Research Site	Iasi
Romania	Research Site	Tg. Mures
Romania	Research Site	Timisoara
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Saint Petersburg
South Africa	Research Site	Bloemfontein
South Africa	Research Site	Cape Town
South Africa	Research Site	Pietermaritzburg
Spain	Research Site	Barcelona
Spain	Research Site	Madrid
Spain	Research Site	Sabadell
Spain	Research Site	Santiago
Sweden	Research Site	Goteborg
Sweden	Research Site	Karlstad
Sweden	Research Site	Kristianstad
Sweden	Research Site	Linköping
Sweden	Research Site	Norrkoping
Sweden	Research Site	Ostersund
Sweden	Research Site	Skövde
Sweden	Research Site	Stockholm
Sweden	Research Site	Sundsvall
Sweden	Research Site	Trollhättan
Turkey	Research Site	Ankara
Turkey	Research Site	Bursa
Turkey	Research Site	Izmir
Turkey	Research Site	Izmit
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Derby
United Kingdom	Research Site	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Austria,  Denmark,  Finland,  France,  Germany,  Greece,  Hong Kong,  Netherlands,  Norway,  Romania,  Russian Federation,  South Africa,  Spain,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo		Within 72 hours	No
Secondary	Clinically Significant Rebleeding Within 7 Days		Within 7 days	No
Secondary	Clinically Significant Rebleeding Within 30 Days		Within 30 days	No
Secondary	Death Within 72 Hours		Within 72 hours	No
Secondary	Death Within 30 Days		Within 30 days	No
Secondary	Death Related to Rebleeding Within 30 Days as Judged by the EpC		Within 30 days	No
Secondary	Requirement for Surgery Within 72 Hours		Within 72 hours	No
Secondary	Requirement for Surgery Within 30 Days		Within 30 days	No
Secondary	Requirement for Endoscopic Re-treatment Within 72 Hours		Within 72 hours	No
Secondary	Requirement for Endoscopic Re-treatment Within 30 Days		Within 30 days	No
Secondary	Number of Blood Units Transfused Within 72 Hours		Within 72 hours	No
Secondary	Number of Blood Units Transfused Within 30 Days		within 30 days	No
Secondary	Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period		Within 30 days	No

External Links

•   AstraZeneca Clinical Trial Information - Outside US