HealthyPhase 1PA32540-109NCT00700687
Study Evaluating the Effect on Gastroduodenal Mucosa of PA32540, PA32540 and Celecoxib, and Aspirin With Celecoxib
A Phase 1 study testing PA32540, PA32540 and celecoxib and aspirin and [NSAID] in people with Healthy, run by POZEN at 1 site in United States.
Trial summary
We will evaluate the effect on the gastroduodenal mucosa from oral dosing of three different treatments Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PA32540, PA32540 and celecoxib and aspirin and [NSAID]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jul 2008
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or non-pregnant female subjects greater than or equal to 50 years as well as other standard inclusion criteria for a study of this nature
Who cannot join
- Standard exclusion criteria for a study of this nature
Trial locations and contacts
1 site in 1 country.
About this study
We will evaluate the effect on the gastroduodenal mucosa from oral dosing of three different treatments
- Conditions
- Healthy
- Being tested
- PA32540, PA32540 and celecoxib, aspirin and [NSAID]
- Keywords
- cardiovascular prophylactic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA32540Drug
aspirin/omeprazole
PA32540 and celecoxibDrug
aspirin/omeprazole and celecoxib
aspirin and [NSAID]Drug
aspirin and [NSAID]
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PA32540 Receives: Drug: PA32540 |
| 2 | Experimental | PA32540 and celecoxib Receives: Drug: PA32540 and celecoxib |
| 3 | Active comparator | aspirin and celecoxib Receives: Drug: aspirin and [NSAID] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lanza scores
Measured: entire course of study
Secondary outcomes (1)
safety of three treatments
Measured: entrie course of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- POZEN
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700687
- Sponsor's protocol ID
- PA32540-109
- Acronym
- PA32540-109
- Status last verified
- Jan 2009
- First submitted
- 4 Jun 2008
- Last updated
- 12 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating the Effect on Gastroduodenal Mucosa of PA32540, PA32540 and Celecoxib, and Aspirin With Celecoxib
- ClinicalTrials.gov ID
- NCT00700687
- Acronym / sponsor ID
- PA32540-109 / PA32540-109
- Conditions
- Healthy
- Keywords
- cardiovascular prophylactic therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- POZENIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 19 Jun 2008 (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.
We will evaluate the effect on the gastroduodenal mucosa from oral dosing of three different treatments
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PA32540PA32540 |
| 2 | Experimental | Drug: PA32540 and celecoxibPA32540 and celecoxib |
| 3 | Active comparator | Drug: aspirin and [NSAID]aspirin and celecoxib |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male or non-pregnant female subjects greater than or equal to 50 years as well as other standard inclusion criteria for a study of this nature
Key exclusion criteria (1 listed)
- Standard exclusion criteria for a study of this nature
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 |
|---|---|---|
| PA32540aspirin/omeprazole | Drug | 1 |
| PA32540 and celecoxibaspirin/omeprazole and celecoxib | Drug | 2 |
| aspirin and [NSAID]aspirin and [NSAID] | Drug | 3 |
Primary outcome
Lanza scores
Time frame: entire course of study
1 secondary outcome
safety of three treatments
Time frame: entrie course of study
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 Jan 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PA32540, PA32540 and celecoxib and aspirin and [NSAID] in people with Healthy, run by POZEN 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 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 12 Jan 2009. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Lanza scores (time frame: entire course of study). 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 Jan 2009.