HealthyPhase 1NCT00548678
Platelet Function and Safety After IV and Oral Diclofenac, IV Ketorolac and Oral Aspirin in Adult Volunteers
A Phase 1 study testing intravenous diclofenac sodium (DIC075V), ketorolac and oral diclofenac (Cataflam) in people with Healthy, run by Javelin Pharmaceuticals at 1 site in United States.
Trial summary
This study will assess platelet function and safety in healthy male volunteers following doses of intravenous diclofenac compared to oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- intravenous diclofenac sodium (DIC075V), ketorolac and oral diclofenac (Cataflam)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Nov 2007
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects.
- Willing and able to stay at the clinical site for approximately 8 nights over 9 days and to return to the clinic approximately 7 days after discharge.
Who cannot join
- Bleeding abnormalities or cardiovascular events.
- Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, Randomized, Single-Dose, Four-Treatment Crossover Study to Evaluate Platelet Function in Healthy Adult Males After Administration of IV Diclofenac Sodium, Oral Diclofenac Potasssium, IV Ketorolac Tromethamine, and Acetylsalicylic Acid
This study will assess platelet function and safety in healthy male volunteers following doses of intravenous diclofenac compared to oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.
Read the detailed description
The primary objective is to evaluate platelet function following intravenous diclofenac, oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.
- Conditions
- Healthy
- Keywords
- diclofenac, platelet aggregation, ketorolac, aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous diclofenac sodium (DIC075V)Drug
intravenous diclofenac sodium
ketorolacDrug
intravenous ketorolac
oral diclofenac (Cataflam)Drug
oral diclofenac (Cataflam)
aspirinDrug
oral aspirin
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | intravenous diclofenac sodium Receives: Drug: intravenous diclofenac sodium (DIC075V) |
| B | Active comparator | intravenous ketorolac Receives: Drug: ketorolac |
| C | Active comparator | oral diclofenac (Cataflam) Receives: Drug: oral diclofenac (Cataflam) |
| D | Active comparator | oral aspirin Receives: Drug: aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the platelet closure time curve from 0-6 hours (AUC 0-6 hours) as measured by the PFA-100.
Measured: 6 hours
Secondary outcomes (1)
The secondary endpoint is the maximum change from baseline in closure time as measured by the PFA-100.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionNov 2007
- Study completionNov 2007
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javelin Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Javelin Pharmaceuticals, Study director, Javelin Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548678
- Sponsor's protocol ID
- DFC-007
- Status last verified
- Jul 2008
- First submitted
- 22 Oct 2007
- Last updated
- 16 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomized, Single-Dose, Four-Treatment Crossover Study to Evaluate Platelet Function in Healthy Adult Males After Administration of IV Diclofenac Sodium, Oral Diclofenac Potasssium, IV Ketorolac Tromethamine, and Acetylsalicylic Acid
- ClinicalTrials.gov ID
- NCT00548678
- Acronym / sponsor ID
- DFC-007
- Conditions
- Healthy
- Keywords
- diclofenac, platelet aggregation, ketorolac, aspirin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Javelin PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 24 Oct 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 will assess platelet function and safety in healthy male volunteers following doses of intravenous diclofenac compared to oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.
Detailed description
The primary objective is to evaluate platelet function following intravenous diclofenac, oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: intravenous diclofenac sodium (DIC075V)intravenous diclofenac sodium |
| B | Active comparator | Drug: ketorolacintravenous ketorolac |
| C | Active comparator | Drug: oral diclofenac (Cataflam)oral diclofenac (Cataflam) |
| D | Active comparator | Drug: aspirinoral aspirin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male subjects.
- Willing and able to stay at the clinical site for approximately 8 nights over 9 days and to return to the clinic approximately 7 days after discharge.
Key exclusion criteria (2 listed)
- Bleeding abnormalities or cardiovascular events.
- Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.
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 |
|---|---|---|
| intravenous diclofenac sodium (DIC075V)intravenous diclofenac sodium | Drug | A |
| ketorolacintravenous ketorolac | Drug | B |
| oral diclofenac (Cataflam)oral diclofenac (Cataflam) | Drug | C |
| aspirinoral aspirin | Drug | D |
Primary outcome
Area under the platelet closure time curve from 0-6 hours (AUC 0-6 hours) as measured by the PFA-100.
Time frame: 6 hours
1 secondary outcome
The secondary endpoint is the maximum change from baseline in closure time as measured by the PFA-100.
Time frame: 6 hours
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 16 Jul 2008.
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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.
Javelin Pharmaceuticals study director
Javelin Pharmaceuticals
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 intravenous diclofenac sodium (DIC075V), ketorolac and oral diclofenac (Cataflam) in people with Healthy, run by Javelin Pharmaceuticals 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 2 inclusion and 2 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 16 Jul 2008. 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?
Area under the platelet closure time curve from 0-6 hours (AUC 0-6 hours) as measured by the PFA-100. (time frame: 6 hours). 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 16 Jul 2008.