Platelet InhibitionPhase 1NCT01094483
A Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN400 and Low Dose Aspirin
A Phase 1 study testing PN400 and ASA in people with Platelet Inhibition, run by AstraZeneca at 1 site in United States.
Trial summary
The primary hypothesis of this study is that concomitant multiple-dose administration of PN 400 does not interfere with the platelet inhibitory effects of enteric-coated low-dose aspirin (81 mg), as measured by serum thromboxane B2 inhibition. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Platelet Inhibition
- What is being tested?
- PN400 and ASA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to May 2010
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stable without clinically significant disease
Who cannot join
- Use of NSAID within 2 weeks
- Type 1 or 2 DM
- GI disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Prospective, Randomized, Double-blind, Placebo-controlled Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN 400 and Low Dose Aspirin
The primary hypothesis of this study is that concomitant multiple-dose administration of PN 400 does not interfere with the platelet inhibitory effects of enteric-coated low-dose aspirin (81 mg), as measured by serum thromboxane B2 inhibition.
- Conditions
- Platelet Inhibition
- Being tested
- PN400, ASA, Placebo
- Keywords
- Thromboxane B2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PN400Drug
naproxen 500 mg/esomeprazole 20 mg oral tablet
ASADrug
Also called Asprin
Asprin 81 mg enteric coated tablet
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PN400 + ASA Receives: Drug: PN400; Drug: ASA |
| 2 | Placebo comparator | Placebo + ASA Receives: Drug: ASA; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic: Mean percent inhibition of serum thromboxane B2
Measured: measured on the morning of Day 6 (Period 1), and 24 hours after the Day 10 morning dose of aspirin (ie, Day 11) in Period 2
Safety: Parameters include: physical examination, vital signs, clinical laboratory tests, adverse events
Measured: during approx 6 week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2010
- Study completionMay 2010
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 Platelet InhibitionStudies 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- POZEN
- Investigators
- Ralph Schutz, MD, Principal investigator, Quintiles Phase 1 ServicesCatherine Datto, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094483
- Sponsor's protocol ID
- D1120C00036
- Status last verified
- Dec 2010
- First submitted
- 25 Mar 2010
- Last updated
- 7 Dec 2010
- Results posted
- No
Publications
Angiolillo DJ, Hwang C, Datto C, Desai B, Sostek M. Impact of a fixed-dose combination of naproxen and esomeprazole magnesium on serum thromboxane B2 inhibition by low-dose aspirin over 5 days in healthy adults: a phase I, randomized, double-blind, placebo-controlled, noninferiority trial. Clin Ther. 2011 Dec;33(12):1883-93. doi: 10.1016/j.clinthera.2011.10.009. Epub 2011 Nov 10.
PubMed 22078153
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Prospective, Randomized, Double-blind, Placebo-controlled Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN 400 and Low Dose Aspirin
- ClinicalTrials.gov ID
- NCT01094483
- Acronym / sponsor ID
- D1120C00036
- Conditions
- Platelet Inhibition
- Keywords
- Thromboxane B2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- POZEN
- Study start
- Mar 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 29 Mar 2010 (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 primary hypothesis of this study is that concomitant multiple-dose administration of PN 400 does not interfere with the platelet inhibitory effects of enteric-coated low-dose aspirin (81 mg), as measured by serum thromboxane B2 inhibition.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PN400, Drug: ASAPN400 + ASA |
| 2 | Placebo comparator | Drug: ASA, Drug: PlaceboPlacebo + ASA |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stable without clinically significant disease
Key exclusion criteria (3 listed)
- Use of NSAID within 2 weeks
- Type 1 or 2 DM
- GI disorder
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 |
|---|---|---|
| PN400naproxen 500 mg/esomeprazole 20 mg oral tablet | Drug | 1 |
| ASAAlso: AsprinAsprin 81 mg enteric coated tablet | Drug | 1, 2 |
| Placebo | Drug | 2 |
Primary outcome
Pharmacodynamic: Mean percent inhibition of serum thromboxane B2
Time frame: measured on the morning of Day 6 (Period 1), and 24 hours after the Day 10 morning dose of aspirin (ie, Day 11) in Period 2
Safety: Parameters include: physical examination, vital signs, clinical laboratory tests, adverse events
Time frame: during approx 6 week study period
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 7 Dec 2010.
- Derived from this study: PubMed 22078153Angiolillo DJ, Hwang C, Datto C, Desai B, Sostek M. Impact of a fixed-dose combination of naproxen and esomeprazole magnesium on serum thromboxane B2 inhibition by low-dose aspirin over 5 days in healthy adults: a phase I, randomized, double-blind, placebo-controlled, noninferiority trial. Clin Ther. 2011 Dec;33(12):1883-93. doi: 10.1016/j.clinthera.2011.10.009. Epub 2011 Nov 10.
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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.
Ralph Schutz, MD principal investigator
Quintiles Phase 1 Services
Catherine Datto, MD study director
AstraZeneca
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 PN400 and ASA in people with Platelet Inhibition, run by AstraZeneca 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 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 7 Dec 2010. 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. Some participants in this study may receive a placebo. 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?
Pharmacodynamic: Mean percent inhibition of serum thromboxane B2 (time frame: measured on the morning of Day 6 (Period 1), and 24 hours after the Day 10 morning dose of aspirin (ie, Day 11) in Period 2). The study lists 2 primary outcomes in all. 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 NCT01094483, 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 7 Dec 2010.