Peptic UlcersPhase 3NCT00374101
High Versus Standard Dose of Proton Pump Inhibitors (PPIs) in Peptic Ulcer Bleeding
A Phase 3 study testing omeprazole and pantoprazole in people with Peptic Ulcers and Upper Gastrointestinal Bleeding, run by Casa Sollievo della Sofferenza IRCCS at 10 sites in Italy.
Trial summary
High intravenous dosage of Proton Pump Inhibitors is not better than standard dosage in bleeding peptic ulcers successfully treated by endoscopic therapy Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Peptic Ulcers, Upper Gastrointestinal Bleeding
- What is being tested?
- omeprazole and pantoprazole
- How many people
- 450 participants
- Where
- 10 sitesItaly
- Study dates
- Jan 2005to Mar 2007
- Phase
- Phase 3
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients admitted for upper gastrointestinal bleeding secondary to peptic ulcers that have been successfully treated with endoscopic therapy
Who cannot join
- Variceal esophageal bleeding
- Concurrent PPI use
- Moribund patients
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites
Division of Gastroenterology
Caserta
DIvision of Gastroenterology
Como
Division of Gastroenterology
Cosenza
DIvision of Internal Medicine
Ivrea
Division of Gastroenterology
Piacenza
Division of Internal Medicine
Polla, Salerno
Division of Gastroenterology
San Giovanni Rotondo
Division of Gastroenterology
Torino
Division of Gastroenterology
Treviso
Division of Gastroenterology
Vasto
About this study
Official title: Proton Pump Inhibitors in Conjunction to Endoscopic Therapy for Bleeding Peptic Ulcers: a Randomized Clinical Trial of High vs Standard Doses
High intravenous dosage of Proton Pump Inhibitors is not better than standard dosage in bleeding peptic ulcers successfully treated by endoscopic therapy
Read the detailed description
The recent Canadian consensus conference on the management of patients with non-variceal upper gastrointestinal bleeding recommends a high regimen of PPIs, consisting in a dosage of 80-mg bolus followed by the 8 mg/H infusion, as being superior to the standard dosage (40 mg twice daily by bolus injection) in conjunction with some type of endoscopic therapy. However, by pooling data fromm studies comparing high doses of PPIs as continuous infusion versus regular doses as intermittent bolus, rebleeding, surgery, and mortality were not significantly different. As the previous conclusion became apparent in a meta-analytical evaluation of only 2 randomized clinical trials, more studies are needed on this topic.
- Conditions
- Peptic Ulcers, Upper Gastrointestinal Bleeding
- Being tested
- omeprazole, pantoprazole
- Keywords
- PPIs,, endoscopic therapy,, peptic ulcers,, upper gastrointestinal bleeding,, non-variceal upper gastrointestinal bleeding
- Medical subject headings
- Peptic Ulcer, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omeprazoleDrug
pantoprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding rates and surgical needs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startJan 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peptic UlcersStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 450 participants
Sponsor and investigators
- Lead sponsor
- Casa Sollievo della Sofferenza IRCCS
- Sponsor type
- University, hospital or other
- Investigators
- Andriulli Angelo, MD, Principal investigator, Division of Gastroenterology, "Casa Sollievo della Sofferenza", San Giovanni Rotondo, ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374101
- Sponsor's protocol ID
- 18/2004
- Status last verified
- Apr 2007
- First submitted
- 7 Sep 2006
- Last updated
- 5 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Andriulli A, Annese V, Caruso N, Pilotto A, Accadia L, Niro AG, Quitadamo M, Merla A, Fiorella S, Leandro G. Proton-pump inhibitors and outcome of endoscopic hemostasis in bleeding peptic ulcers: a series of meta-analyses. Am J Gastroenterol. 2005 Jan;100(1):207-19. doi: 10.1111/j.1572-0241.2005.40636.x.
PubMed 15654802Andriulli A, Loperfido S, Focareta R, Leo P, Fornari F, Garripoli A, Tonti P, Peyre S, Spadaccini A, Marmo R, Merla A, Caroli A, Forte GB, Belmonte A, Aragona G, Imperiali G, Forte F, Monica F, Caruso N, Perri F. High- versus low-dose proton pump inhibitors after endoscopic hemostasis in patients with peptic ulcer bleeding: a multicentre, randomized study. Am J Gastroenterol. 2008 Dec;103(12):3011-8. doi: 10.1111/j.1572-0241.2008.02149.x.
PubMed 19086953
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Pump Inhibitors in Conjunction to Endoscopic Therapy for Bleeding Peptic Ulcers: a Randomized Clinical Trial of High vs Standard Doses
- ClinicalTrials.gov ID
- NCT00374101
- Acronym / sponsor ID
- 18/2004
- Conditions
- Peptic Ulcers, Upper Gastrointestinal Bleeding
- Keywords
- PPIs,, endoscopic therapy,, peptic ulcers,, upper gastrointestinal bleeding,, non-variceal upper gastrointestinal bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- Casa Sollievo della Sofferenza IRCCSUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 8 Sep 2006 (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.
High intravenous dosage of Proton Pump Inhibitors is not better than standard dosage in bleeding peptic ulcers successfully treated by endoscopic therapy
Detailed description
The recent Canadian consensus conference on the management of patients with non-variceal upper gastrointestinal bleeding recommends a high regimen of PPIs, consisting in a dosage of 80-mg bolus followed by the 8 mg/H infusion, as being superior to the standard dosage (40 mg twice daily by bolus injection) in conjunction with some type of endoscopic therapy. However, by pooling data fromm studies comparing high doses of PPIs as continuous infusion versus regular doses as intermittent bolus, rebleeding, surgery, and mortality were not significantly different. As the previous conclusion became apparent in a meta-analytical evaluation of only 2 randomized clinical trials, more studies are needed on this topic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients admitted for upper gastrointestinal bleeding secondary to peptic ulcers that have been successfully treated with endoscopic therapy
Key exclusion criteria (3 listed)
- Variceal esophageal bleeding
- Concurrent PPI use
- Moribund patients
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 |
|---|---|---|
| omeprazole | Drug | – |
| pantoprazole | Drug | – |
Primary outcome
Rebleeding rates and surgical needs
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 5 Apr 2007.
- Background: PubMed 15654802Andriulli A, Annese V, Caruso N, Pilotto A, Accadia L, Niro AG, Quitadamo M, Merla A, Fiorella S, Leandro G. Proton-pump inhibitors and outcome of endoscopic hemostasis in bleeding peptic ulcers: a series of meta-analyses. Am J Gastroenterol. 2005 Jan;100(1):207-19. doi: 10.1111/j.1572-0241.2005.40636.x.
- Derived from this study: PubMed 19086953Andriulli A, Loperfido S, Focareta R, Leo P, Fornari F, Garripoli A, Tonti P, Peyre S, Spadaccini A, Marmo R, Merla A, Caroli A, Forte GB, Belmonte A, Aragona G, Imperiali G, Forte F, Monica F, Caruso N, Perri F. High- versus low-dose proton pump inhibitors after endoscopic hemostasis in patients with peptic ulcer bleeding: a multicentre, randomized study. Am J Gastroenterol. 2008 Dec;103(12):3011-8. doi: 10.1111/j.1572-0241.2008.02149.x.
Related trials for Peptic Ulcers
Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer
Active, not recruiting
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
Gastritis Chronic, Gastroduodenitis
RecruitingPhase 4
Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection
Ulcers, Gastric
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
RecruitingObservational study
Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU
Stress Ulcers, Reflux Episodes
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.
Andriulli Angelo, MD principal investigator
Division of Gastroenterology, "Casa Sollievo della Sofferenza", San Giovanni Rotondo, ITALY
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing omeprazole and pantoprazole in people with Peptic Ulcers and Upper Gastrointestinal Bleeding, run by Casa Sollievo della Sofferenza IRCCS at 10 sites in Italy.
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 1 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 5 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. 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?
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?
Rebleeding rates and surgical needs. 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 NCT00374101, which also lists 2 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 5 Apr 2007.