Human EndotoxaemiaPhase 4NCT01087359
Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia
A Phase 4 study testing Melatonin in people with Human Endotoxaemia, run by Herlev Hospital at 1 site in Denmark.
Trial summary
This is a double blinded, randomised, crossover study with 12 healthy men between 18 and 40 year. The design is based on 6 days: day 1: On day time administration of LPS. day 2: On night time administration of LPS. day 3: On day time administration of LPS + Placebo. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Endotoxaemia
- What is being tested?
- Melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2010to Feb 2011
- 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 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men
- Age 18-49 year.
- Healthy
- No sleepiness disorders.
- No medication
- ASA I
Who cannot join
- Allergia to melatonin
- Women
- Smoking.
- Alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
This is a double blinded, randomised, crossover study with 12 healthy men between 18 and 40 year. The design is based on 6 days:
- day 1: On day time administration of LPS.
- day 2: On night time administration of LPS.
- day 3: On day time administration of LPS + Placebo.
- day 4: On day time administration of LPS + melatonin.
- day 5: On night time administration of LPS + placebo.
- day 6: On night time administration og LPS + melatonin.
Measuring the inflammatoric and oxidative response of LPS and the effect of melatonin compared to placebo on the endotoxaemia.
- Conditions
- Human Endotoxaemia
- Being tested
- Melatonin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
| Study group | Role | What they receive |
|---|---|---|
| LPS + melatonin night | Active comparator | Not described Receives: Drug: Melatonin |
| LPS + placebo night | Placebo comparator | Not described Receives: Drug: Melatonin |
| LPS + melatonin day | Active comparator | Not described Receives: Drug: Melatonin |
| LPS + placebo day | Placebo comparator | Not described Receives: Drug: Melatonin |
| LPS night | Experimental | Not described Receives: Drug: Melatonin |
| LPS day | Experimental | Not described Receives: Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatoric markers
IL-6 TNF-alpha YKL-40
Measured: measured before and after the administration of LPS endotoxin.
Oxidative markers
Vit C MDA (malondialdehyde)
Measured: measured before and after the administration of LPS endotoxin.
Secondary outcomes (1)
Secondary outcome
Holter Fatigue Karolinska Sleepness scale Blood pressure Heart rate Temperature
Measured: constant measurment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human EndotoxaemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087359
- Sponsor's protocol ID
- H-2-2010-010
- Status last verified
- Oct 2010
- First submitted
- 15 Mar 2010
- Last updated
- 20 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia
- ClinicalTrials.gov ID
- NCT01087359
- Acronym / sponsor ID
- H-2-2010-010
- Conditions
- Human Endotoxaemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 16 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.
This is a double blinded, randomised, crossover study with 12 healthy men between 18 and 40 year. The design is based on 6 days:
- day 1: On day time administration of LPS.
- day 2: On night time administration of LPS.
- day 3: On day time administration of LPS + Placebo.
- day 4: On day time administration of LPS + melatonin.
- day 5: On night time administration of LPS + placebo.
- day 6: On night time administration og LPS + melatonin.
Measuring the inflammatoric and oxidative response of LPS and the effect of melatonin compared to placebo on the endotoxaemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LPS + melatonin night | Active comparator | Drug: Melatonin |
| LPS + placebo night | Placebo comparator | Drug: Melatonin |
| LPS + melatonin day | Active comparator | Drug: Melatonin |
| LPS + placebo day | Placebo comparator | Drug: Melatonin |
| LPS night | Experimental | Drug: Melatonin |
| LPS day | Experimental | Drug: Melatonin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Men
- Age 18-49 year.
- Healthy
- No sleepiness disorders.
- No medication
Key exclusion criteria (4 listed)
- Allergia to melatonin
- Women
- Smoking.
- Alcohol abuse.
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 |
|---|---|---|
| Melatonin100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo | Drug | LPS + melatonin day, LPS + melatonin night, LPS + placebo day, LPS + placebo night, LPS day, LPS night |
Primary outcome
Inflammatoric markers
Time frame: measured before and after the administration of LPS endotoxin.
IL-6 TNF-alpha YKL-40
Oxidative markers
Time frame: measured before and after the administration of LPS endotoxin.
Vit C MDA (malondialdehyde)
1 secondary outcome
Secondary outcome
Time frame: constant measurment
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 20 Jun 2011.
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 4 study testing Melatonin in people with Human Endotoxaemia, run by Herlev Hospital at 1 site in Denmark.
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 6 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 20 Jun 2011. 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 Denmark. 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 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?
Inflammatoric markers (time frame: measured before and after the administration of LPS endotoxin.). 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 20 Jun 2011.