The Analgesic Effects of Melatonin
1 other identifier
interventional
36
1 country
1
Brief Summary
A study investigating the analgesic effect of melatonin in a human heat injury model using quantitative sensory testing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 8, 2013
CompletedFirst Posted
Study publicly available on registry
August 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedOctober 22, 2014
October 1, 2014
10 months
August 8, 2013
October 21, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Pain (VAS)
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
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
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
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
1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration
Study Arms (3)
Placebo
PLACEBO COMPARATORIV formulation
Melatonin 10 mg
ACTIVE COMPARATORIV formulation, Melatonin 10 mg
Melatonin 100 mg
ACTIVE COMPARATORIV formulation, Melatonin 100 mg
Interventions
Eligibility Criteria
You may qualify if:
- Healthy males aged between 20 and 40 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lars Peter Holst Andersenlead
- University of Copenhagencollaborator
Study Sites (1)
Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet
Copenhagen, 2200, Denmark
Related Publications (1)
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.
PMID: 26893170DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lars P.H. Andersen, MD
Herlev Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Ph.d. fellow
Study Record Dates
First Submitted
August 8, 2013
First Posted
August 16, 2013
Study Start
August 1, 2013
Primary Completion
June 1, 2014
Study Completion
August 1, 2014
Last Updated
October 22, 2014
Record last verified: 2014-10