Gastric UlcerPhase 4NCT00428701
An Open-label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium
A Phase 4 study testing Esomeprazole Sodium in people with Gastric Ulcer, run by AstraZeneca at 5 sites in United States.
Trial summary
This study is being done to see if Nexium I.V. can reduce and control stomach acid in mechanically ventilated, critically ill patients in an Intensive Care Unit setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Ulcer
- What is being tested?
- Esomeprazole Sodium
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2006to Nov 2006
- Phase
- Phase 4
- 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
- Critically ill male or female subjects 18 years or older who have a baseline gastric aspirate pH less then or equal to 4
- Subjects admitted to an ICU requiring mechanically ventilated
- Subjects will have at least one additional stress ulcer risk factor
Who cannot join
- Anticipated use of pre-pyloric enteral feeding after screening until the end of study
- Physician estimated survival of less then 96 hours
- Anticipation of major surgery within 96 hours of study enrollment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Research Site
Hershey, Pennsylvania
Research Site
Memphis, Tennessee
Research Site
Nashville, Tennessee
Research SIte
Newark, Delaware
Research Site
Shreveport, Louisiana
About this study
Official title: An Open-Label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium I.V. (Esomeprazole Sodium) 40mg BID for up to 72 Hours
This study is being done to see if Nexium I.V. can reduce and control stomach acid in mechanically ventilated, critically ill patients in an Intensive Care Unit setting.
- Conditions
- Gastric Ulcer
- Being tested
- Esomeprazole Sodium
- Keywords
- stress ulcer, critically ill, gastric acid, gastric aspirates, esomeprazole
- Medical subject headings
- Stomach Ulcer, Duodenal Ulcer, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole SodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects
Secondary outcomes (1)
The secondary objective is to assess time to stable pH greater then or equal to 4 from start of drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startOct 2006
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric UlcerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Sostek, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428701
- Sponsor's protocol ID
- D9612L00107
- Other IDs
- Nexium IV ICU Study 107
- Status last verified
- Jan 2011
- First submitted
- 29 Jan 2007
- Last updated
- 24 Jan 2011
- Results posted
- No
Publications
Metz DC, Fulda GJ, Olsen KM, Monyak JT, Simonson SG, Sostek MB. Intravenous esomeprazole pharmacodynamics in critically ill patients. Curr Med Res Opin. 2010 May;26(5):1141-8. doi: 10.1185/03007991003694308.
PubMed 20230209
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium I.V. (Esomeprazole Sodium) 40mg BID for up to 72 Hours
- ClinicalTrials.gov ID
- NCT00428701
- Acronym / sponsor ID
- D9612L00107
- Conditions
- Gastric Ulcer
- Keywords
- stress ulcer, critically ill, gastric acid, gastric aspirates, esomeprazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 30 Jan 2007 (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.
This study is being done to see if Nexium I.V. can reduce and control stomach acid in mechanically ventilated, critically ill patients in an Intensive Care Unit setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Critically ill male or female subjects 18 years or older who have a baseline gastric aspirate pH less then or equal to 4
- Subjects admitted to an ICU requiring mechanically ventilated
- Subjects will have at least one additional stress ulcer risk factor
Key exclusion criteria (3 listed)
- Anticipated use of pre-pyloric enteral feeding after screening until the end of study
- Physician estimated survival of less then 96 hours
- Anticipation of major surgery within 96 hours of study enrollment
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 Sodium | Drug | – |
Primary outcome
The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects
1 secondary outcome
The secondary objective is to assess time to stable pH greater then or equal to 4 from start of drug
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 24 Jan 2011.
- Derived from this study: PubMed 20230209Metz DC, Fulda GJ, Olsen KM, Monyak JT, Simonson SG, Sostek MB. Intravenous esomeprazole pharmacodynamics in critically ill patients. Curr Med Res Opin. 2010 May;26(5):1141-8. doi: 10.1185/03007991003694308.
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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.
Mark Sostek, MD study director
AstraZeneca
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esomeprazole Sodium in people with Gastric Ulcer, run by AstraZeneca at 5 sites in United States.
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 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 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects. 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 NCT00428701, which also lists 1 linked publication.
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 24 Jan 2011.