Stomach UlcerPhase 4NCT00239551
Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer
A Phase 4 study testing Prevacid in people with Stomach Ulcer, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to measure the prostaglandin levels in patients with stress ulcer and the effect of Prevacid on prostaglandin levels in patients with stress ulcer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Ulcer
- What is being tested?
- Prevacid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Dec 2007
- 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
- Patients in ICU with documented gastric stress ulcer by endoscopic examination, including patients with H. Pylori infection;
- Patients have no known ulcer within 8 weeks prior to be admitted to ICU;
- Patients not on any PPI for 4 weeks prior to the study;
- Patients or family be consented for the study.
Who cannot join
- Patients have gastric ulcer within 8 weeks prior to be admitted to ICU;
- Patients have gastric cancer confirmed by pathology;
- Patients on one of the PPIs already;
- Patients on any of the Non-steroidal Antiinflammatory Drugs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University School of Medicine
Atlanta, Georgia, 30322
About this study
Official title: Effect of Prevacid on Prostaglandin Levels in the Gastric Mucosa of Patients With Stress Ulcer
The purpose of this study is to measure the prostaglandin levels in patients with stress ulcer and the effect of Prevacid on prostaglandin levels in patients with stress ulcer.
Read the detailed description
The prostaglandin system plays an important role in the gastric mucosa to strengthen its resistance against injury. Critically ill patients are at greatest risk of developing stress-related gastric mucosal lesions. Although the levels of prostaglandins in gastric mucosa in patients with stressed animal has been studied, prostaglandin levels in the gastric mucosa in patients with stress ulcer have not been studied and the effect of Prevacid on prostaglandin levels in gastric mucosa from patients with stress ulcer is unknown.
We hypothesize that prostaglandin levels are low in the gastric mucosa in patients with stress ulcer, and Prevacid is an effective agents in increasing prostaglandin levels in the gastric mucosa in stress stress ulcer.
Comparison(s): The prostaglandin levels in patients who treated with Prevacid for stress ulcer, compared to the prostaglandin levels in patients who treated with H2 blocker for stress ulcer.
- Conditions
- Stomach Ulcer
- Being tested
- Prevacid
- Keywords
- gastric stress ulcer, Prevacid, Prostaglandin
- Medical subject headings
- Stomach Ulcer, Duodenal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrevacidDrug
Also called Lansoprazole
Effect of Prevacid on prostaglandin levels at 8 weeks; EGD (esophagogastroduodenal endoscopy) with biopsy at day 1 \& EGD with biopsy at 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Prevacid | Experimental | Effect of Prevacid at 8 weeks; EGD(esophagogastroduodenal endoscopy) at day 1 \& EGD at 8 weeks Receives: Drug: Prevacid |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of Prevacid on prostaglandin levels at 8 weeks
Measured: 8 weeks
Secondary outcomes (1)
esophagogastroduodenal endoscopy(EGD) with biopsy at day 1; EGD with biopsy at 8 weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionOct 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach UlcerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- TAP Pharmaceutical Products Inc.
- Responsible party
- Principal investigator, Dr. Qiang Cai MD/PhD, Emory University
- Investigators
- Qiang Cai, MD, PhD, Principal investigator, Emory UniversityVincent W Yang, MD, PhD, Study director, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239551
- Sponsor's protocol ID
- 623-2005
- Status last verified
- Jul 2013
- First submitted
- 13 Oct 2005
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prevacid on Prostaglandin Levels in the Gastric Mucosa of Patients With Stress Ulcer
- ClinicalTrials.gov ID
- NCT00239551
- Acronym / sponsor ID
- 623-2005
- Conditions
- Stomach Ulcer
- Keywords
- gastric stress ulcer, Prevacid, Prostaglandin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- TAP Pharmaceutical Products Inc.
- Study start
- Oct 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 17 Oct 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.
The purpose of this study is to measure the prostaglandin levels in patients with stress ulcer and the effect of Prevacid on prostaglandin levels in patients with stress ulcer.
Detailed description
The prostaglandin system plays an important role in the gastric mucosa to strengthen its resistance against injury. Critically ill patients are at greatest risk of developing stress-related gastric mucosal lesions. Although the levels of prostaglandins in gastric mucosa in patients with stressed animal has been studied, prostaglandin levels in the gastric mucosa in patients with stress ulcer have not been studied and the effect of Prevacid on prostaglandin levels in gastric mucosa from patients with stress ulcer is unknown.
We hypothesize that prostaglandin levels are low in the gastric mucosa in patients with stress ulcer, and Prevacid is an effective agents in increasing prostaglandin levels in the gastric mucosa in stress stress ulcer.
Comparison(s): The prostaglandin levels in patients who treated with Prevacid for stress ulcer, compared to the prostaglandin levels in patients who treated with H2 blocker for stress ulcer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevacid | Experimental | Drug: PrevacidEffect of Prevacid at 8 weeks; EGD(esophagogastroduodenal endoscopy) at day 1 \& EGD at 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients in ICU with documented gastric stress ulcer by endoscopic examination, including patients with H. Pylori infection;
- Patients have no known ulcer within 8 weeks prior to be admitted to ICU;
- Patients not on any PPI for 4 weeks prior to the study;
- Patients or family be consented for the study.
Key exclusion criteria (4 listed)
- Patients have gastric ulcer within 8 weeks prior to be admitted to ICU;
- Patients have gastric cancer confirmed by pathology;
- Patients on one of the PPIs already;
- Patients on any of the Non-steroidal Antiinflammatory Drugs.
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 |
|---|---|---|
| PrevacidAlso: LansoprazoleEffect of Prevacid on prostaglandin levels at 8 weeks; EGD (esophagogastroduodenal endoscopy) with biopsy at day 1 \& EGD with biopsy at 8 weeks | Drug | Prevacid |
Primary outcome
the effect of Prevacid on prostaglandin levels at 8 weeks
Time frame: 8 weeks
1 secondary outcome
esophagogastroduodenal endoscopy(EGD) with biopsy at day 1; EGD with biopsy at 8 weeks
Time frame: 8 weeks
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 31 Jul 2013.
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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.
Qiang Cai, MD, PhD principal investigator
Emory University
Vincent W Yang, MD, PhD study director
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prevacid in people with Stomach Ulcer, run by Emory University at 1 site 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 4 inclusion and 4 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 31 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 effect of Prevacid on prostaglandin levels at 8 weeks (time frame: 8 weeks). 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 31 Jul 2013.