HealthyPhase 4NCT02140372
Anti-platelet Effects of Colchicine in Healthy Volunteers
A Phase 4 study testing Colchicine in people with Healthy, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a pilot study. Volunteers will be given 1.8 mg (1.2 mg followed by 0.6 mg one hour later), 1.2 mg, or 0.6 mg of colchicine. Blood will be collected prior to drug administration, 2 hours after colchicine administration, and 24 hours after colchicine administration via the antecubital vein and evaluated for… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Colchicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jan 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be more than 18 years of age
Who cannot join
- 1) history of cardiovascular disease, including myocardial infarction, history of percutaneous coronary angioplasty or stent, peripheral vascular disease or stroke; 2) history of myelodysplasia; 3) medications known to affect platelet function, including non-steroidal anti-inflammatory drugs, antihistamines, and selective serotonin reuptake inhibitors, during the 5 days prior to participation; 4) medications known to interact with colchicine; 5) history of intolerance to colchicine; 6) acute or chronic symptoms of diarrhea, nausea, or vomiting within 1 month prior to enrollment; 7) known anemia or hemoglobin <10mg/dL; 8) platelet count <100,000 or > 450,000; 9) creatinine clearance <30cc/minute; 10) any known hemorrhagic diathesis; 11) pregnant; 12) Unable to consent; or 13) Participating in a competing study.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
This is a pilot study. Volunteers will be given 1.8 mg (1.2 mg followed by 0.6 mg one hour later), 1.2 mg, or 0.6 mg of colchicine. Blood will be collected prior to drug administration, 2 hours after colchicine administration, and 24 hours after colchicine administration via the antecubital vein and evaluated for markers of platelet activity and inflammation.
- Conditions
- Healthy
- Being tested
- Colchicine
- Keywords
- colchicine, platelet activity, neutrophil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Also called Colcrys
Colchicine 1.2 mg followed by 0.6 mg one hour later
| Study group | Role | What they receive |
|---|---|---|
| Volunteer group | Experimental | Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later Receives: Drug: Colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocyte Platelet Aggregate: Baseline
Measured: Baseline
Monocyte Platelet Aggregate: 2 Hours
Measured: 2 Hours
Secondary outcomes (6)
Light Transmission Aggregometry: Baseline
In response to adenosine diphosphate
Measured: Baseline
Light Transmission Aggregometry: 2 Hours
In response to adenosine diphosphate
Measured: 2 hours
Light Transmission Aggregometry: Baseline
In response to adenosine epinephrine
Measured: baseline
Light Transmission Aggregometry: 2 Hours
In response to adenosine epinephrine
Measured: 2 hours
Platelet Adhesion: Baseline
Measured: Baseline
Platelet Adhesion: 2 Hours
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binita Shah, MD, MS, Principal investigator, NYU SOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140372
- Sponsor's protocol ID
- S13-00747
- Status last verified
- Jan 2016
- First submitted
- 14 May 2014
- Last updated
- 23 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-platelet Effects of Colchicine in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02140372
- Acronym / sponsor ID
- S13-00747
- Conditions
- Healthy
- Keywords
- colchicine, platelet activity, neutrophil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Posted 23 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study. Volunteers will be given 1.8 mg (1.2 mg followed by 0.6 mg one hour later), 1.2 mg, or 0.6 mg of colchicine. Blood will be collected prior to drug administration, 2 hours after colchicine administration, and 24 hours after colchicine administration via the antecubital vein and evaluated for markers of platelet activity and inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteer group | Experimental | Drug: ColchicineBaseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects must be more than 18 years of age
Key exclusion criteria (1 listed)
- 1) history of cardiovascular disease, including myocardial infarction, history of percutaneous coronary angioplasty or stent, peripheral vascular disease or stroke; 2) history of myelodysplasia; 3) medications known to affect platelet function, including non-steroidal anti-inflammatory drugs, antihistamines, and selective serotonin reuptake inhibitors, during the 5 days prior to participation; 4) medications known to interact with colchicine; 5) history of intolerance to colchicine; 6) acute or chronic symptoms of diarrhea, nausea, or vomiting within 1 month prior to enrollment; 7) known anemia or hemoglobin <10mg/dL; 8) platelet count <100,000 or > 450,000; 9) creatinine clearance <30cc/minute; 10) any known hemorrhagic diathesis; 11) pregnant; 12) Unable to consent; or 13) Participating in a competing 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 |
|---|---|---|
| ColchicineAlso: ColcrysColchicine 1.2 mg followed by 0.6 mg one hour later | Drug | Volunteer group |
Primary outcome
Monocyte Platelet Aggregate: Baseline
Time frame: Baseline
Monocyte Platelet Aggregate: 2 Hours
Time frame: 2 Hours
6 secondary outcomes
Light Transmission Aggregometry: Baseline
Time frame: Baseline
Light Transmission Aggregometry: 2 Hours
Time frame: 2 hours
Light Transmission Aggregometry: Baseline
Time frame: baseline
Light Transmission Aggregometry: 2 Hours
Time frame: 2 hours
Platelet Adhesion: Baseline
Time frame: Baseline
Platelet Adhesion: 2 Hours
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Binita Shah, MD, MS principal investigator
NYU SOM
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 Colchicine in people with Healthy, run by NYU Langone Health 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 23 Feb 2016. 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?
Yes. Results are posted in the registry (first posted 23 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Monocyte Platelet Aggregate: Baseline (time frame: Baseline). 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?
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 23 Feb 2016.