Peptic UlcersPhase 4NCT00137033
Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population
A Phase 4 study testing Celecoxib, Naproxen and ASA in people with Peptic Ulcers, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 23 sites in United States.
Trial summary
The aim of the current study is to replicate the COXA-0508-258 study in a multicenter, US setting, using a lower dose of ASA. It is expected that this study will not only confirm the results of the 258 study but show that the incidence of UGI ulcers on celecoxib is significantly less than on traditional NSAIDs and the… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Peptic Ulcers
- What is being tested?
- Celecoxib, Naproxen and ASA
- How many people
- 605 participants
- Where
- 23 sitesUnited States
- Study dates
- Sep 2004to Jul 2005
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A healthy adult between 50 and 75 years of age inclusive: of normal clinical laboratory test results during the Screening Visit or, if abnormal, are not clinically significant in the Investigator's opinion.
Who cannot join
- A gastric, pyloric channel or duodenal ulcer (defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth) or more than 5 erosions in the stomach or duodenum ( the UGI endoscopic score greater or less) on the baseline UGI endoscopy
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Pfizer Investigational Site
Anaheim, California, 92801
Pfizer Investigational Site
Charlottesville, Virginia, 22903
Pfizer Investigational Site
Chattanooga, Tennessee, 37404
Pfizer Investigational Site
Chesapeake, Virginia, 23320-1706
Pfizer Investigational Site
Chevy Chase, Maryland, 20815
Pfizer Investigational Site
Chicago, Illinois, 60612-7323
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Davenport, Iowa, 52807
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635
Pfizer Investigational Site
Farmington, Connecticut, 06030-0001
Pfizer Investigational Site
Houston, Texas, 77074
Pfizer Investigational Site
Houston, Texas, 77090
Pfizer Investigational Site
Jupiter, Florida, 33458
Pfizer Investigational Site
Metairie, Louisiana, 70001
Pfizer Investigational Site
Miami, Florida, 33173
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
Newburgh, Indiana, 47630
Pfizer Investigational Site
Ocoee, Florida, 34761
Pfizer Investigational Site
Pembroke Pines, Florida, 33024
Pfizer Investigational Site
Raleigh, North Carolina, 27612
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
Waterbury, Connecticut, 06708
Pfizer Investigational Site
Wilmington, North Carolina, 28401
About this study
Official title: A Multicenter, Randomized, Active-Controlled Comparison Study of the Incidence of Gastroduodenal Ulcers Associated With Celecoxib and Low Dose ASA Versus Naproxen and Low Dose ASA in Healthy Subjects (50-75 Years of Age)
The aim of the current study is to replicate the COXA-0508-258 study in a multicenter, US setting, using a lower dose of ASA. It is expected that this study will not only confirm the results of the 258 study but show that the incidence of UGI ulcers on celecoxib is significantly less than on traditional NSAIDs and the incidence of UGI ulcers on celecoxib increases with the addition of ASA, but still is lower than traditional NSAIDs plus/minus ASA. This 7-day study is designed to compare the incidence of gastroduodenal ulcers associated with celecoxib 200 mg QD and low dose aspirin 81 mg QD and with naproxen 500 mg BID plus low dose aspirin 81 mg QD in healthy adults(50-75 years of age).
- Conditions
- Peptic Ulcers
- Being tested
- Celecoxib, Naproxen, ASA
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
NaproxenDrug
ASADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the incidence of gastroduodenal endoscopic ulcers between celecoxib 200 mg QD plus ASA 81 mg QD vs. naproxen 500 mg BID plus ASA 81 mg QD in healthy subjects (50-75 years old).
Secondary outcomes (1)
Compare the incidence of gastroduodenal endoscopic ulcers between celecoxib plus ASA vs placebo plus ASA in healthy subjects (50-75 years of age) Compare the incidence of gastroduodenal endoscopic ulcers between naproxen plus ASA vs. placebo plus ASA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startSep 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 605 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137033
- Sponsor's protocol ID
- A3191171
- Status last verified
- Mar 2021
- First submitted
- 26 Aug 2005
- Last updated
- 3 Mar 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Active-Controlled Comparison Study of the Incidence of Gastroduodenal Ulcers Associated With Celecoxib and Low Dose ASA Versus Naproxen and Low Dose ASA in Healthy Subjects (50-75 Years of Age)
- ClinicalTrials.gov ID
- NCT00137033
- Acronym / sponsor ID
- A3191171
- Conditions
- Peptic Ulcers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 605 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Jul 2005 (actual)
- First posted
- 29 Aug 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 aim of the current study is to replicate the COXA-0508-258 study in a multicenter, US setting, using a lower dose of ASA. It is expected that this study will not only confirm the results of the 258 study but show that the incidence of UGI ulcers on celecoxib is significantly less than on traditional NSAIDs and the incidence of UGI ulcers on celecoxib increases with the addition of ASA, but still is lower than traditional NSAIDs plus/minus ASA. This 7-day study is designed to compare the incidence of gastroduodenal ulcers associated with celecoxib 200 mg QD and low dose aspirin 81 mg QD and with naproxen 500 mg BID plus low dose aspirin 81 mg QD in healthy adults(50-75 years of age).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A healthy adult between 50 and 75 years of age inclusive: of normal clinical laboratory test results during the Screening Visit or, if abnormal, are not clinically significant in the Investigator's opinion.
Key exclusion criteria (1 listed)
- A gastric, pyloric channel or duodenal ulcer (defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth) or more than 5 erosions in the stomach or duodenum ( the UGI endoscopic score greater or less) on the baseline UGI endoscopy
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 |
|---|---|---|
| Celecoxib | Drug | – |
| Naproxen | Drug | – |
| ASA | Drug | – |
Primary outcome
Compare the incidence of gastroduodenal endoscopic ulcers between celecoxib 200 mg QD plus ASA 81 mg QD vs. naproxen 500 mg BID plus ASA 81 mg QD in healthy subjects (50-75 years old).
1 secondary outcome
Compare the incidence of gastroduodenal endoscopic ulcers between celecoxib plus ASA vs placebo plus ASA in healthy subjects (50-75 years of age) Compare the incidence of gastroduodenal endoscopic ulcers between naproxen plus ASA vs. placebo plus ASA
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 3 Mar 2021.
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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.
Pfizer CT.gov Call Center study director
Pfizer
23 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 Celecoxib, Naproxen and ASA in people with Peptic Ulcers, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 23 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 1 inclusion and 1 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 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
Compare the incidence of gastroduodenal endoscopic ulcers between celecoxib 200 mg QD plus ASA 81 mg QD vs. naproxen 500 mg BID plus ASA 81 mg QD in healthy subjects (50-75 years old).. 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 3 Mar 2021.