Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
36 participants
INTERVENTIONAL
2013-08-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Placebo
IV formulation
Placebo
Melatonin 10 mg
IV formulation, Melatonin 10 mg
Melatonin 10 mg
Melatonin 100 mg
IV formulation, Melatonin 100 mg
Melatonin 100 mg
Interventions
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Melatonin 10 mg
Melatonin 100 mg
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
20 Years
40 Years
MALE
Yes
Sponsors
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University of Copenhagen
OTHER
Lars Peter Holst Andersen
OTHER
Responsible Party
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Lars Peter Holst Andersen
Ph.d. fellow
Principal Investigators
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Lars P.H. Andersen, MD
Role: PRINCIPAL_INVESTIGATOR
Herlev Hospital
Locations
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Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet
Copenhagen, , Denmark
Countries
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References
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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.
Other Identifiers
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CPO-2013
Identifier Type: -
Identifier Source: org_study_id
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