PainPhase 4ScDexNCT02724098
Bioavailability of Subcutaneous Dexmedetomidine
A Phase 4 study testing Dexmedetomidine in people with Pain, run by Turku University Hospital at 1 site in Finland.
Trial summary
The aim of this study is to investigate the pharmacokinetics of subcutaneously administered dexmedetomidine in healthy volunteers. The absolute bioavailability of subcutaneously administered dexmedetomidine will be calculated. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2016to May 2017
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fluent skills in the Finnish language in order to be able to give informed consent and communicate with the study personnel.
- Age ≥ 18 years.
- Male gender.
- Weight ≥ 60 kg.
- Written informed consent from the subject.
Who cannot join
- Previous history of intolerance to the study drug or related compounds and additives.
- Concomitant drug therapy of any kind except paracetamol in the 14 days prior to the study.
- Existing or recent significant disease.
- History of any kind of drug allergy.
- Previous or present alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.
- Donation of blood within six weeks prior to and during the study.
Show all 10Show fewer
- Body weight < 60 kg or BMI > 30 kg / m2.
- Participation in any other clinical study involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
- Smoking during one month before the start of the study or during the study period.
- Clinically significant abnormal findings in physical examination, ECG or laboratory screening
Trial locations and contacts
1 site in 1 country.
Finland1 site
Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital
Turku, 20521
About this study
Official title: Bioavailability of Subcutaneously Given Dexmedetomidine in Healthy Volunteers
The aim of this study is to investigate the pharmacokinetics of subcutaneously administered dexmedetomidine in healthy volunteers. The absolute bioavailability of subcutaneously administered dexmedetomidine will be calculated. In addition, the investigators will report the effects of subcutaneously administered dexmedetomidine on plasma catecholamine levels, vital signs such as systemic blood pressure, heart rate and sedation. The investigators will also monitor the local and systemic safety and tolerability of subcutaneously administered dexmedetomidine.
- Conditions
- Pain
- Being tested
- Dexmedetomidine
- Keywords
- Palliative Therapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
| Study group | Role | What they receive |
|---|---|---|
| intravenous | Active comparator | 1 µg/kg dexmedetomidine (dexmedetomidine hydrochloride 100 microg/ml, Dexdor® Orion Oyj, Espoo, Finland) diluted in 10 ml of sodium chloride will be administered intravenously in 10 min at a constant rate using an infusion pump. Receives: Drug: Dexmedetomidine |
| subcutaneous | Active comparator | 1 µg/kg dexmedetomidine (dexmedetomidine hydrochloride 100 microg/ml, Dexdor® Orion Oyj, Espoo, Finland) will be administered subcutaneously undiluted. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability (%) of subcutaneously given dexmedetomidine
Noncompartmental analysis after non-linear mixed effects modelling.
Measured: 10 hours
Secondary outcomes (3)
Change in hemodynamic parameter (blood pressure)
More than 30% change from the baseline in the blood pressure (measured in mmHg)
Measured: 10 hours
Number of participants with adverse events as a measure of safety and tolerability
Measured: 7 days
Change in hemodynamic parameter (heart rate)
More than 30% change from the baseline in the blood pressure (measured in beats/minute)
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Teijo I Saari, MD, PhD, Principal investigator, Dept. Anaesthesiology and Intensive Care, University Of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724098
- Sponsor's protocol ID
- T30/2016
- Acronym
- ScDex
- Status last verified
- Sep 2017
- First submitted
- 12 Feb 2016
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ashraf MW, Uusalo P, Scheinin M, Saari TI. Population Modelling of Dexmedetomidine Pharmacokinetics and Haemodynamic Effects After Intravenous and Subcutaneous Administration. Clin Pharmacokinet. 2020 Nov;59(11):1467-1482. doi: 10.1007/s40262-020-00900-3.
PubMed 32462542Uusalo P, Al-Ramahi D, Tilli I, Aantaa RA, Scheinin M, Saari TI. Subcutaneously administered dexmedetomidine is efficiently absorbed and is associated with attenuated cardiovascular effects in healthy volunteers. Eur J Clin Pharmacol. 2018 Aug;74(8):1047-1054. doi: 10.1007/s00228-018-2461-1. Epub 2018 Apr 17.
PubMed 29666901
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Subcutaneously Given Dexmedetomidine in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02724098
- Acronym / sponsor ID
- ScDex / T30/2016
- Conditions
- Pain
- Keywords
- Palliative Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Apr 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 31 Mar 2016 (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 this study is to investigate the pharmacokinetics of subcutaneously administered dexmedetomidine in healthy volunteers. The absolute bioavailability of subcutaneously administered dexmedetomidine will be calculated. In addition, the investigators will report the effects of subcutaneously administered dexmedetomidine on plasma catecholamine levels, vital signs such as systemic blood pressure, heart rate and sedation. The investigators will also monitor the local and systemic safety and tolerability of subcutaneously administered dexmedetomidine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous | Active comparator | Drug: Dexmedetomidine1 µg/kg dexmedetomidine (dexmedetomidine hydrochloride 100 microg/ml, Dexdor® Orion Oyj, Espoo, Finland) diluted in 10 ml of sodium chloride will be administered intravenously in 10 min at a constant rate using an infusion pump. |
| subcutaneous | Active comparator | Drug: Dexmedetomidine1 µg/kg dexmedetomidine (dexmedetomidine hydrochloride 100 microg/ml, Dexdor® Orion Oyj, Espoo, Finland) will be administered subcutaneously undiluted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fluent skills in the Finnish language in order to be able to give informed consent and communicate with the study personnel.
- Age ≥ 18 years.
- Male gender.
- Weight ≥ 60 kg.
- Written informed consent from the subject.
Key exclusion criteria (10 listed)
- Previous history of intolerance to the study drug or related compounds and additives.
- Concomitant drug therapy of any kind except paracetamol in the 14 days prior to the study.
- Existing or recent significant disease.
- History of any kind of drug allergy.
- Previous or present alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.
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 |
|---|---|---|
| Dexmedetomidine | Drug | intravenous, subcutaneous |
Primary outcome
Bioavailability (%) of subcutaneously given dexmedetomidine
Time frame: 10 hours
Noncompartmental analysis after non-linear mixed effects modelling.
3 secondary outcomes
Change in hemodynamic parameter (blood pressure)
Time frame: 10 hours
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 7 days
Change in hemodynamic parameter (heart rate)
Time frame: 10 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 12 Sep 2017.
- Derived from this study: PubMed 32462542Ashraf MW, Uusalo P, Scheinin M, Saari TI. Population Modelling of Dexmedetomidine Pharmacokinetics and Haemodynamic Effects After Intravenous and Subcutaneous Administration. Clin Pharmacokinet. 2020 Nov;59(11):1467-1482. doi: 10.1007/s40262-020-00900-3.
- Derived from this study: PubMed 29666901Uusalo P, Al-Ramahi D, Tilli I, Aantaa RA, Scheinin M, Saari TI. Subcutaneously administered dexmedetomidine is efficiently absorbed and is associated with attenuated cardiovascular effects in healthy volunteers. Eur J Clin Pharmacol. 2018 Aug;74(8):1047-1054. doi: 10.1007/s00228-018-2461-1. Epub 2018 Apr 17.
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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.
Teijo I Saari, MD, PhD principal investigator
Dept. Anaesthesiology and Intensive Care, University Of Turku
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 Dexmedetomidine in people with Pain, run by Turku University Hospital at 1 site in Finland.
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 5 inclusion and 10 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 Sep 2017. 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 Finland. 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?
Bioavailability (%) of subcutaneously given dexmedetomidine (time frame: 10 hours). 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 NCT02724098, which also lists 2 linked publications.
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 Sep 2017.