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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

Tracking Information
First Submitted Date  ICMJE August 8, 2013
First Posted Date  ICMJE August 16, 2013
Last Update Posted Date October 22, 2014
Study Start Date  ICMJE August 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2013)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Analgesic Effects of Melatonin
Official Title  ICMJE The Analgesic Effects of Melatonin: A Randomized, Placebo-controlled, Double-blinded Study on Healthy Volunteers
Brief Summary A study investigating the analgesic effect of melatonin in a human heat injury model using quantitative sensory testing.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Analgesia
  • Antihyperalgesia
Intervention  ICMJE
  • Drug: Melatonin 10 mg
  • Drug: Melatonin 100 mg
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    IV formulation
    Intervention: Drug: Placebo
  • Active Comparator: Melatonin 10 mg
    IV formulation, Melatonin 10 mg
    Intervention: Drug: Melatonin 10 mg
  • Active Comparator: Melatonin 100 mg
    IV formulation, Melatonin 100 mg
    Intervention: Drug: Melatonin 100 mg
Publications * Andersen LP, Werner MU, Rosenkilde MM, Harpsøe NG, Fuglsang H, Rosenberg J, Gögenur 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 15, 2013)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01923974
Other Study ID Numbers  ICMJE CPO-2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lars Peter Holst Andersen, Herlev Hospital
Study Sponsor  ICMJE Lars Peter Holst Andersen
Collaborators  ICMJE University of Copenhagen
Investigators  ICMJE
Principal Investigator: Lars P.H. Andersen, MD Herlev Hospital
PRS Account Herlev Hospital
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP