AnalgesiaPhase 2/3NCT01923974
The Analgesic Effects of Melatonin
A Phase 2/3 study testing Melatonin 10 mg and Melatonin 100 mg in people with Analgesia and Antihyperalgesia, run by Lars Peter Holst Andersen at 1 site in Denmark.
Trial summary
A study investigating the analgesic effect of melatonin in a human heat injury model using quantitative sensory testing. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Antihyperalgesia
- What is being tested?
- Melatonin 10 mg and Melatonin 100 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2013to Aug 2014
- Phase
- Phase 2/3
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males aged between 20 and 40 years
Who cannot join
- Under aged/minors
- Does not speak or understand danish
- Alcohol or abuse of medicines
- Prior QST-trial within the last 2 month
- Prior medical trail within the last month
- Serious comorbidity (ASA-class 3-4)
- Chronic pain (defined by analgesic treatment) Shift-work or night work within the last 14 days Known sleep-disorder
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet
Copenhagen, 2200
About this study
Official title: The Analgesic Effects of Melatonin: A Randomized, Placebo-controlled, Double-blinded Study on Healthy Volunteers
A study investigating the analgesic effect of melatonin in a human heat injury model using quantitative sensory testing.
- Conditions
- Analgesia, Antihyperalgesia
- Being tested
- Melatonin 10 mg, Melatonin 100 mg, Placebo
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 10 mgDrug
Melatonin 100 mgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | IV formulation Receives: Drug: Placebo |
| Melatonin 10 mg | Active comparator | IV formulation, Melatonin 10 mg Receives: Drug: Melatonin 10 mg |
| Melatonin 100 mg | Active comparator | IV formulation, Melatonin 100 mg Receives: Drug: Melatonin 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (VAS)
Measured: During burn injury. 1 hours following melatonin/placebo administration
Change in areas of secondary hyperalgesia
Areas of secondary hyperalgesia will be assessed by quantitative sensory testing
Measured: 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration
Secondary outcomes (3)
Change in erythema/oedema assessed by ultrasound
Measured: 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration
Thermal thresholds assessed by quantitative sensory testing
Measured: 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration
Mechanical thresholds assessed quantitative sensory testing
Measured: 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies 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 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lars Peter Holst Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor-investigator, Lars Peter Holst Andersen, Herlev Hospital
- Investigators
- Lars P.H. Andersen, MD, Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923974
- Sponsor's protocol ID
- CPO-2013
- Status last verified
- Oct 2014
- First submitted
- 8 Aug 2013
- Last updated
- 22 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Andersen LP, Werner MU, Rosenkilde MM, Harpsoe NG, Fuglsang H, Rosenberg J, Gogenur I. Pharmacokinetics of oral and intravenous melatonin in healthy volunteers. BMC Pharmacol Toxicol. 2016 Feb 19;17:8. doi: 10.1186/s40360-016-0052-2.
PubMed 26893170
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Effects of Melatonin: A Randomized, Placebo-controlled, Double-blinded Study on Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01923974
- Acronym / sponsor ID
- CPO-2013
- Conditions
- Analgesia, Antihyperalgesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Lars Peter Holst AndersenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Aug 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 16 Aug 2013 (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.
A study investigating the analgesic effect of melatonin in a human heat injury model using quantitative sensory testing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboIV formulation |
| Melatonin 10 mg | Active comparator | Drug: Melatonin 10 mgIV formulation, Melatonin 10 mg |
| Melatonin 100 mg | Active comparator | Drug: Melatonin 100 mgIV formulation, Melatonin 100 mg |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy males aged between 20 and 40 years
Key exclusion criteria (7 listed)
- Under aged/minors
- Does not speak or understand danish
- Alcohol or abuse of medicines
- Prior QST-trial within the last 2 month
- Prior medical trail within the last month
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 10 mg | Drug | Melatonin 10 mg |
| Melatonin 100 mg | Drug | Melatonin 100 mg |
| Placebo | Drug | Placebo |
Primary outcome
Pain (VAS)
Time frame: During burn injury. 1 hours following melatonin/placebo administration
Change in areas of secondary hyperalgesia
Time frame: 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration
Areas of secondary hyperalgesia will be assessed by quantitative sensory testing
3 secondary outcomes
Change in erythema/oedema assessed by ultrasound
Time frame: 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration
Thermal thresholds assessed by quantitative sensory testing
Time frame: 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration
Mechanical thresholds assessed quantitative sensory testing
Time frame: 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration
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 22 Oct 2014.
- Derived from this study: PubMed 26893170Andersen LP, Werner MU, Rosenkilde MM, Harpsoe NG, Fuglsang H, Rosenberg J, Gogenur I. Pharmacokinetics of oral and intravenous melatonin in healthy volunteers. BMC Pharmacol Toxicol. 2016 Feb 19;17:8. doi: 10.1186/s40360-016-0052-2.
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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.
Lars P.H. Andersen, MD principal investigator
Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Melatonin 10 mg and Melatonin 100 mg in people with Analgesia and Antihyperalgesia, run by Lars Peter Holst Andersen 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 1 inclusion and 7 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 22 Oct 2014. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pain (VAS) (time frame: During burn injury. 1 hours following melatonin/placebo administration). 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?
On the ClinicalTrials.gov record for NCT01923974, which also lists 1 linked publication.
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 22 Oct 2014; AzTrials last refreshed its copy on 3 Nov 2026.