Peptic UlcerPhase 2NCT00152399
Study to Assess the Efficacy and Safety of Somatostatin in the Treatment of Acute Severe Upper Gastrointestinal Bleeding
A Phase 2 study testing Somatostatin UCB (drug) in people with Peptic Ulcer, run by UCB Pharma at 22 sites in 6 countries.
Trial summary
To assess the efficacy and safety of the early administration of somatostatin in infusion during 72 hours plus 2 boluses, compared to placebo in the control of acute severe UGIB with suspicion of PUB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer
- What is being tested?
- Somatostatin UCB (drug)
- How many people
- 370 participants
- Where
- 22 sitesin 6 countries
- Study dates
- Sep 2000to Oct 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Male or female non-cirrhotic patients at least 18 years old suspected to bleed from PU.
- Patients with haematemesis and/or hematochezia and/or melena which have been observed by a member of a clinical team (GP, hospital physician, nurse, ...).
- Either, documented signs of hypovolemia related to the current bleeding episode Or, occurrence of symptoms of hypovolemia
Who cannot join
- Treatment of the present bleeding episode with somatostatin or its analogues, vasoactive drugs, or endoscopic therapy.
- Any treatment with PPIs (IV or per os) within the last 48 hours preceding randomisation.
- Treatment (endotherapy or pharmacotherapy) for upper gastrointestinal ulcer bleeding in the last 30 days.
- Deficient haemostasis (platelets < 40 x 109/l, international normalised ratio of the prothrombin time > 1.5 (or prothrombin time < 70%), or activated partial thromboplastin time > 40 seconds (or according to the normal ranges validated, from local lab))
- Anticoagulant therapy (vitamin K antagonists or heparin including LMW heparins)
- Terminal stage illness in which endoscopy is contraindicated
Trial locations and contacts
22 sites in 6 countries.
22 sites in 6 countries
France5 sites
Study site
Angers
Study site
Bobigny
Study site
Créteil
Study site
Paris
Study site
Villejuif
Hungary5 sites
Study site
Budapest
Study site
Debrecen
Study site
Győr
Study site
Kaposvár
Study site
Vác
Poland4 sites
Study site
Bydgoszcz
Study site
Krakow
Study site
Pruszków
Study site
Warsaw
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial To Study The Efficacy And The Safety Of The Early Administration Of Somatostatin (Ucb) 12 Mg/24 H IV Infusion And Two IV Boluses Of 250 Mcg During 72 Hours In The Treatment Of Subjects With Acute Severe Upper Gastrointestinal Bleeding (UGIB) With Suspicion Of Peptic Ulcer Bleeding [The PUB Study]
To assess the efficacy and safety of the early administration of somatostatin in infusion during 72 hours plus 2 boluses, compared to placebo in the control of acute severe UGIB with suspicion of PUB.
- Conditions
- Peptic Ulcer
- Being tested
- Somatostatin UCB (drug)
- Keywords
- Peptic ulcer bleeding, upper intestinal bleeding, endoscopy, somatostatin
- Medical subject headings
- Peptic Ulcer, Peptic Ulcer Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatostatin UCB (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy and safety of the early IV administration of somatostatin during 72 hours compared to placebo in the control of acute severe UGIB with suspicion of PUB by measuring the failure rate
Secondary outcomes (1)
To evaluate the difference between somatostatin and placebo on the following variables; Type of failure; Time to failure(h) up to 72 hours; Mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startSep 2000
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic UlcerStudies of the same condition, open and under way.
- 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 370 participants
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tatiana Kharkevitch, MD, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152399
- Sponsor's protocol ID
- 9823
- Status last verified
- Sep 2012
- First submitted
- 7 Sep 2005
- Last updated
- 18 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial To Study The Efficacy And The Safety Of The Early Administration Of Somatostatin (Ucb) 12 Mg/24 H IV Infusion And Two IV Boluses Of 250 Mcg During 72 Hours In The Treatment Of Subjects With Acute Severe Upper Gastrointestinal Bleeding (UGIB) With Suspicion Of Peptic Ulcer Bleeding [The PUB Study]
- ClinicalTrials.gov ID
- NCT00152399
- Acronym / sponsor ID
- 9823
- Conditions
- Peptic Ulcer
- Keywords
- Peptic ulcer bleeding, upper intestinal bleeding, endoscopy, somatostatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2000
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy and safety of the early administration of somatostatin in infusion during 72 hours plus 2 boluses, compared to placebo in the control of acute severe UGIB with suspicion of PUB.
Study design
- 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 (3 listed)
- Male or female non-cirrhotic patients at least 18 years old suspected to bleed from PU.
- Patients with haematemesis and/or hematochezia and/or melena which have been observed by a member of a clinical team (GP, hospital physician, nurse, ...).
- Either, documented signs of hypovolemia related to the current bleeding episode Or, occurrence of symptoms of hypovolemia
Key exclusion criteria (6 listed)
- Treatment of the present bleeding episode with somatostatin or its analogues, vasoactive drugs, or endoscopic therapy.
- Any treatment with PPIs (IV or per os) within the last 48 hours preceding randomisation.
- Treatment (endotherapy or pharmacotherapy) for upper gastrointestinal ulcer bleeding in the last 30 days.
- Deficient haemostasis (platelets < 40 x 109/l, international normalised ratio of the prothrombin time > 1.5 (or prothrombin time < 70%), or activated partial thromboplastin time > 40 seconds (or according to the normal ranges validated, from local lab))
- Anticoagulant therapy (vitamin K antagonists or heparin including LMW heparins)
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 |
|---|---|---|
| Somatostatin UCB (drug) | Drug | – |
Primary outcome
To assess the efficacy and safety of the early IV administration of somatostatin during 72 hours compared to placebo in the control of acute severe UGIB with suspicion of PUB by measuring the failure rate
1 secondary outcome
To evaluate the difference between somatostatin and placebo on the following variables; Type of failure; Time to failure(h) up to 72 hours; Mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
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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.
Tatiana Kharkevitch, MD study director
UCB Pharma
22 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Somatostatin UCB (drug) in people with Peptic Ulcer, run by UCB Pharma at 22 sites in 6 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 3 inclusion and 6 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 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France, Hungary, Poland, Belgium, Spain and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the efficacy and safety of the early IV administration of somatostatin during 72 hours compared to placebo in the control of acute severe UGIB with suspicion of PUB by measuring the failure rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2012; AzTrials last refreshed its copy on 8 Nov 2026.