Gastrointestinal HemorrhagePhase 3NCT00251979
A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer
A Phase 3 study testing Esomeprazole in people with Gastrointestinal Hemorrhage, run by AstraZeneca at 78 sites in 16 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Hemorrhage
- What is being tested?
- Esomeprazole
- How many people
- 1,312 participants
- Where
- 78 sitesin 16 countries
- Study dates
- Oct 2005to Dec 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signs of a bleeding in the stomach
- One endoscopically confirmed bleeding ulcer in the stomach or duodenum
Who cannot join
- Malignancy or other advanced disease.
- Major cardiovascular event.
- Severe hepatic disease
Trial locations and contacts
78 sites in 16 countries.
78 sites in 16 countries
Sweden10 sites
Research Site
Gothenburg
Research Site
Karlstad
Research Site
Kristianstad
Research Site
Linköping
Research Site
Norrköping
Research Site
Östersund
Research Site
Skövde
Research Site
Stockholm
Research Site
Sundsvall
Research Site
Trollhättan
Germany9 sites
Research Site
Berlin
Research Site
Bochum
Research Site
Celle
Research Site
Dresden
Research Site
Karlsruhe
Research Site
Leipzig
Research Site
Ludwigshafen
Research Site
Magdeburg
Research Site
Weimar
Denmark8 sites
Research Site
Aalborg
Research Site
Amager
Research Site
Copenhagen
Research Site
Glostrup Municipality
Research Site
Holstebro
Research Site
Odense
Research Site
Randers
Research Site
Slagelse
France7 sites
Research Site
Amiens
Research Site
Bordeaux
Research Site
Clermont-Ferrand
Research Site
Lille
Research Site
Nice
Research Site
Paris
Research Site
Rouen
Austria6 sites
Research Site
Braunau/Inn
Research Site
Feldbach
Research Site
Graz
Research Site
Krems
Research Site
Vienna
Research Site
Wels
Netherlands6 sites
Research Site
Arnhem
Research Site
Dordrecht
Research Site
Hengelo
Research Site
Nieuwegein
Research Site
Rotterdam
Research Site
Zwolle
Norway6 sites
Research Site
Ålesund
Research Site
Drammen
Research Site
Kristiansand
Research Site
Lorenskog
Research Site
Oslo
Research Site
Tønsberg
Romania5 sites
Research Site
Bucharest
Research Site
Craiova
Research Site
Iași
Research Site
Tg. Mures
Research Site
Timișoara
Spain4 sites
Research Site
Barcelona
Research Site
Madrid
Research Site
Sabadell
Research Site
Santiago
Turkey (Türkiye)4 sites
Research Site
Ankara
Research Site
Bursa
Research Site
Izmir
Research Site
İzmit
South Africa3 sites
Research Site
Bloemfontein
Research Site
Cape Town
Research Site
Pietermaritzburg
United Kingdom3 sites
Research Site
Birmingham
Research Site
Derby
Research Site
Leeds
About this study
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.
This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.
- Conditions
- Gastrointestinal Hemorrhage
- Being tested
- Esomeprazole
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo
Measured: Within 72 hours
Secondary outcomes (12)
Clinically Significant Rebleeding Within 7 Days
Measured: Within 7 days
Clinically Significant Rebleeding Within 30 Days
Measured: Within 30 days
Death Within 72 Hours
Measured: Within 72 hours
Death Within 30 Days
Measured: Within 30 days
Death Related to Rebleeding Within 30 Days as Judged by the EpC
Measured: Within 30 days
Requirement for Surgery Within 72 Hours
Measured: Within 72 hours
Requirement for Surgery Within 30 Days
Measured: Within 30 days
Requirement for Endoscopic Re-treatment Within 72 Hours
Measured: Within 72 hours
Requirement for Endoscopic Re-treatment Within 30 Days
Measured: Within 30 days
Number of Blood Units Transfused Within 72 Hours
Measured: Within 72 hours
Number of Blood Units Transfused Within 30 Days
Measured: within 30 days
Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period
Measured: Within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startOct 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,312 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Nexium Medical Sciences Director, Study director, AstraZenecaJoseph Sung, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251979
- Sponsor's protocol ID
- D961DC00001
- Status last verified
- May 2011
- First submitted
- 9 Nov 2005
- Last updated
- 17 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 28070941Kuipers 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.
PubMed 21181319Barkun 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.
PubMed 20151726Sung 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.
PubMed 19221370
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00251979
- Acronym / sponsor ID
- D961DC00001
- Conditions
- Gastrointestinal Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,312 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 11 Nov 2005 (estimated)
- Results
- Posted 17 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signs of a bleeding in the stomach
- One endoscopically confirmed bleeding ulcer in the stomach or duodenum
Key exclusion criteria (3 listed)
- Malignancy or other advanced disease.
- Major cardiovascular event.
- Severe hepatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esomeprazole | Drug | – |
Primary outcome
Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo
Time frame: Within 72 hours
12 secondary outcomes
Clinically Significant Rebleeding Within 7 Days
Time frame: Within 7 days
Clinically Significant Rebleeding Within 30 Days
Time frame: Within 30 days
Death Within 72 Hours
Time frame: Within 72 hours
Death Within 30 Days
Time frame: Within 30 days
Death Related to Rebleeding Within 30 Days as Judged by the EpC
Time frame: Within 30 days
Requirement for Surgery Within 72 Hours
Time frame: Within 72 hours
Requirement for Surgery Within 30 Days
Time frame: Within 30 days
Requirement for Endoscopic Re-treatment Within 72 Hours
Time frame: Within 72 hours
Requirement for Endoscopic Re-treatment Within 30 Days
Time frame: Within 30 days
Number of Blood Units Transfused Within 72 Hours
Time frame: Within 72 hours
Number of Blood Units Transfused Within 30 Days
Time frame: within 30 days
Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period
Time frame: Within 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28070941Lau 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.
- Derived from this study: PubMed 21181319Kuipers 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.
- Derived from this study: PubMed 20151726Barkun 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.
- Derived from this study: PubMed 19221370Sung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Nexium Medical Sciences Director study director
AstraZeneca
Joseph Sung, MD principal investigator
Chinese University of Hong Kong
78 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esomeprazole in people with Gastrointestinal Hemorrhage, run by AstraZeneca at 78 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in Sweden, Germany, Denmark, France, Austria and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo (time frame: Within 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00251979, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2011.