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The Analgesic Effects of Melatonin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01923974
Recruitment Status : Completed
First Posted : August 16, 2013
Last Update Posted : October 22, 2014
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Lars Peter Holst Andersen, Herlev Hospital

Brief Summary:
A study investigating the analgesic effect of melatonin in a human heat injury model using quantitative sensory testing.

Condition or disease Intervention/treatment Phase
Analgesia Antihyperalgesia Drug: Melatonin 10 mg Drug: Melatonin 100 mg Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Analgesic Effects of Melatonin: A Randomized, Placebo-controlled, Double-blinded Study on Healthy Volunteers
Study Start Date : August 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Placebo Comparator: Placebo
IV formulation
Drug: Placebo
Active Comparator: Melatonin 10 mg
IV formulation, Melatonin 10 mg
Drug: Melatonin 10 mg
Active Comparator: Melatonin 100 mg
IV formulation, Melatonin 100 mg
Drug: Melatonin 100 mg



Primary Outcome Measures :
  1. Pain (VAS) [ Time Frame: During burn injury. 1 hours following melatonin/placebo administration ]
  2. 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


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males aged between 20 and 40 years

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923974


Locations
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Denmark
Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet
Copenhagen, Denmark, 2200
Sponsors and Collaborators
Lars Peter Holst Andersen
University of Copenhagen
Investigators
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Principal Investigator: Lars P.H. Andersen, MD Herlev Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lars Peter Holst Andersen, Ph.d. fellow, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01923974    
Other Study ID Numbers: CPO-2013
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants