Spinal Cord Injured, TetraplegiaPhase 1COMENCT01741389
The Role of Melatonin in the Regulation of Blood Coagulation
A Phase 1 study testing Melatonin ("Circadin") in people with Spinal Cord Injured, Tetraplegia, run by University of Oslo at 1 site in Norway.
Trial summary
The main aim is to examine the influence of daylight and melatonin on the temporal variations of hemostatic factors with key roles in the hemostatic process and its regulation. Particular emphasis will be on exploring the role of melatonin in hemostasis by comparing subjects with tetraplegia with able-bodied control… 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
- Spinal Cord Injured, Tetraplegia
- What is being tested?
- Melatonin ("Circadin")
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2012to Mar 2014
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Intervention group:
- A diagnosis of tetraplegia for at least 2 years, and otherwise healthy.
- Must not use drugs permanently (except anti-spasmolytics).
- Must be able to swallow tablets.
- Must give written consent to participate.
- Control group:
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- Must be healthy.
- Must not use drugs permanently.
- Must give written consent to participate.
Who cannot join
- Both groups:
- Those with acute or chronic co-morbidity.
- Unable to cooperate.
- Not provided written consent to participate.
Trial locations and contacts
1 site in 1 country.
About this study
The main aim is to examine the influence of daylight and melatonin on the temporal variations of hemostatic factors with key roles in the hemostatic process and its regulation. Particular emphasis will be on exploring the role of melatonin in hemostasis by comparing subjects with tetraplegia with able-bodied control subjects.
- Conditions
- Spinal Cord Injured, Tetraplegia
- Being tested
- Melatonin ("Circadin")
- Keywords
- Circadian variation, hemostasis, melatonin, tetraplegia
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin ("Circadin")Drug
| Study group | Role | What they receive |
|---|---|---|
| Sleep only | Placebo comparator | Placebo given at night to tetraplegic individuals before going to sleep, Receives: Drug: Melatonin ("Circadin") |
| Melatonin | Active comparator | Melatonin given at night to tetraplegic individuals before going to sleep. Receives: Drug: Melatonin ("Circadin") |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circadian variation of hemostatic factors
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injured, TetraplegiaStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnaas Hospital, Oslo University Hospital
- Responsible party
- Principal investigator, Per Ole Iversen, MD, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741389
- Sponsor's protocol ID
- 2009/295
- Acronym
- COME
- Status last verified
- Oct 2017
- First submitted
- 30 Nov 2012
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Dahm A, Osterud B, Hjeltnes N, Sandset PM, Iversen PO. Opposite circadian rhythms in melatonin and tissue factor pathway inhibitor type 1: does daylight affect coagulation? J Thromb Haemost. 2006 Aug;4(8):1840-2. doi: 10.1111/j.1538-7836.2006.02048.x. No abstract available.
PubMed 16879232Kostovski E, Dahm AE, Iversen N, Hjeltnes N, Osterud B, Sandset PM, Iversen PO. Melatonin stimulates release of tissue factor pathway inhibitor from the vascular endothelium. Blood Coagul Fibrinolysis. 2011 Jun;22(4):254-9. doi: 10.1097/MBC.0b013e3283442ce2.
PubMed 21297449Dahm AE, Iversen PO, Hjeltnes N, Sandset PM. Differences in circadian variations of tissue factor pathway inhibitor type 1 between able-bodied and spinal cord injured. Thromb Res. 2006;118(2):281-7. doi: 10.1016/j.thromres.2005.07.021. Epub 2005 Aug 31.
PubMed 16139333
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Melatonin in the Regulation of Blood Coagulation
- ClinicalTrials.gov ID
- NCT01741389
- Acronym / sponsor ID
- COME / 2009/295
- Conditions
- Spinal Cord Injured, Tetraplegia
- Keywords
- Circadian variation, hemostasis, melatonin, tetraplegia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Sunnaas Hospital, Oslo University Hospital
- Study start
- Dec 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 4 Dec 2012 (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 main aim is to examine the influence of daylight and melatonin on the temporal variations of hemostatic factors with key roles in the hemostatic process and its regulation. Particular emphasis will be on exploring the role of melatonin in hemostasis by comparing subjects with tetraplegia with able-bodied control subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep only | Placebo comparator | Drug: Melatonin ("Circadin")Placebo given at night to tetraplegic individuals before going to sleep, |
| Melatonin | Active comparator | Drug: Melatonin ("Circadin")Melatonin given at night to tetraplegic individuals before going to sleep. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A diagnosis of tetraplegia for at least 2 years, and otherwise healthy.
- Must not use drugs permanently (except anti-spasmolytics).
- Must be able to swallow tablets.
- Must give written consent to participate.
- Must be healthy.
Key exclusion criteria (4 listed)
- Those with acute or chronic co-morbidity.
- Unable to cooperate.
- Not provided written consent to participate.
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 |
|---|---|---|
| Melatonin ("Circadin") | Drug | Melatonin, Sleep only |
Primary outcome
Circadian variation of hemostatic factors
Time frame: 24 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 Oct 2017.
- Background: PubMed 16879232Dahm A, Osterud B, Hjeltnes N, Sandset PM, Iversen PO. Opposite circadian rhythms in melatonin and tissue factor pathway inhibitor type 1: does daylight affect coagulation? J Thromb Haemost. 2006 Aug;4(8):1840-2. doi: 10.1111/j.1538-7836.2006.02048.x. No abstract available.
- Background: PubMed 21297449Kostovski E, Dahm AE, Iversen N, Hjeltnes N, Osterud B, Sandset PM, Iversen PO. Melatonin stimulates release of tissue factor pathway inhibitor from the vascular endothelium. Blood Coagul Fibrinolysis. 2011 Jun;22(4):254-9. doi: 10.1097/MBC.0b013e3283442ce2.
- Background: PubMed 16139333Dahm AE, Iversen PO, Hjeltnes N, Sandset PM. Differences in circadian variations of tissue factor pathway inhibitor type 1 between able-bodied and spinal cord injured. Thromb Res. 2006;118(2):281-7. doi: 10.1016/j.thromres.2005.07.021. Epub 2005 Aug 31.
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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 Melatonin ("Circadin") in people with Spinal Cord Injured, Tetraplegia, run by University of Oslo at 1 site in Norway.
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 9 inclusion and 4 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 Oct 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 Norway. 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?
Circadian variation of hemostatic factors (time frame: 24 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 NCT01741389, which also lists 3 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 16 Oct 2017.