Gastrointestinal HemorrhagePhase 3NCT00402259
Efficacy and Safety Study of Esomeprazole vs Omeprazole to Treat Acute Non-Variceal Upper Gastrointestinal Bleeding
A Phase 3 study testing Esomeprazole IV and Omeprazole IV in people with Gastrointestinal Hemorrhage, run by AstraZeneca at 7 sites in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of Esomeprazole and Omeprazole intravenous every 12 hours for 5 days in subjects with acute non-variceal upper gastrointestinal bleeding Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastrointestinal Hemorrhage
- What is being tested?
- Esomeprazole IV and Omeprazole IV
- Type of treatment
- Injection or infusion
- How many people
- 440 participants
- Where
- 7 sitesChina
- Study dates
- Aug 2006to Oct 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18-65 years.
- GI bleeding or with such signs within 48 hours as judged by the investigator as to have non-variceal upper GI bleeding.
- One endoscopically confirmed bleeding peptic ulcer or erosive gastritis
Who cannot join
- GI bleeding caused by Esophageal varices
- Mallory Weiss syndrome
- Zollinger-Ellison syndrome
- Suspicion of gastric malignancy at baseline endoscopy
- Post-Billroth-resection
- Unknown source of GI bleeding · 2.Unstable vital signs
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Research Site
Beijing
Research site
Fuzhou, Fujian
Research Site
Guangzhou, Guangdong
Research Site
Shanghai
Research Site
Tianjin
Research Site
Wuhan, Hubei
Research Site
Xi’an, Shanxi
About this study
Official title: A Randomised, Double-Blind, Double-Dummy, Active-Controlled, Multicenter Study to Assess the Efficacy and Safety of Esomeprazole or Omeprazole for 5 Days in Subjects With Acute Non-Variceal Upper Gastrointestinal Bleeding
The purpose of this study is to assess the efficacy and safety of Esomeprazole and Omeprazole intravenous every 12 hours for 5 days in subjects with acute non-variceal upper gastrointestinal bleeding
- Conditions
- Gastrointestinal Hemorrhage
- Being tested
- Esomeprazole IV, Omeprazole IV
- Keywords
- acute non-variceal upper gastrointestinal bleeding
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole IVDrug
Omeprazole IVDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy by assessment of proportion of subjects who present with no clinically significant bleeding after 5 days treatment
Secondary outcomes (2)
Proportion of subjects who present with no clinically significant upper GI bleeding after 72-hour treatment
Time to absence of clinically significant upper GI bleeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startAug 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tore Lind, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402259
- Sponsor's protocol ID
- D961DL00004
- Other IDs
- Nexium PUB
- Status last verified
- Mar 2009
- First submitted
- 17 Nov 2006
- Last updated
- 12 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Double-Dummy, Active-Controlled, Multicenter Study to Assess the Efficacy and Safety of Esomeprazole or Omeprazole for 5 Days in Subjects With Acute Non-Variceal Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT00402259
- Acronym / sponsor ID
- D961DL00004
- Conditions
- Gastrointestinal Hemorrhage
- Keywords
- acute non-variceal upper gastrointestinal bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Study completion
- Oct 2007 (actual)
- First posted
- 22 Nov 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.
The purpose of this study is to assess the efficacy and safety of Esomeprazole and Omeprazole intravenous every 12 hours for 5 days in subjects with acute non-variceal upper gastrointestinal bleeding
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female aged 18-65 years.
- GI bleeding or with such signs within 48 hours as judged by the investigator as to have non-variceal upper GI bleeding.
- One endoscopically confirmed bleeding peptic ulcer or erosive gastritis
Key exclusion criteria (6 listed)
- GI bleeding caused by Esophageal varices
- Mallory Weiss syndrome
- Zollinger-Ellison syndrome
- Suspicion of gastric malignancy at baseline endoscopy
- Post-Billroth-resection
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 IV | Drug | – |
| Omeprazole IV | Drug | – |
Primary outcome
Evaluate the efficacy by assessment of proportion of subjects who present with no clinically significant bleeding after 5 days treatment
2 secondary outcomes
Proportion of subjects who present with no clinically significant upper GI bleeding after 72-hour treatment
Time to absence of clinically significant upper GI bleeding
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 12 Mar 2009.
Related trials for Gastrointestinal Hemorrhage
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
Active, not recruitingObservational study
Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Major Gastrointestinal Bleeding (MGIB)
RecruitingPhase 2
Fecal Microbiota Transplantation for Radiation-Induced Proctopathy
Radiation Induced Proctitis
Recruiting
OTSC vs. Angiographic Embolization in Patients With Refractory Non-variceal Upper Gastrointestinal Bleeding
Upper Gastrointestinal Bleeding
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.
Tore Lind, MD study director
AstraZeneca
7 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 Esomeprazole IV and Omeprazole IV in people with Gastrointestinal Hemorrhage, run by AstraZeneca at 7 sites in China.
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 12 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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?
Evaluate the efficacy by assessment of proportion of subjects who present with no clinically significant bleeding after 5 days treatment. 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 12 Mar 2009.