The Analgesic Effects of Melatonin

Analgesia Clinical Trial

Official title:

The Analgesic Effects of Melatonin: A Randomized, Placebo-controlled, Double-blinded Study on Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923974
• Other study ID #: CPO-2013
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 8, 2013
• Last updated: October 21, 2014
• Start date: August 2013
• Est. completion date: August 2014

Study information

• Verified date: October 2014
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Analgesia
• Antihyperalgesia

Intervention

Drug:
• Melatonin 10 mg

• Melatonin 100 mg

• Placebo

Locations

Country	Name	City	State
Denmark	Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Lars Peter Holst Andersen	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (VAS)		During burn injury. 1 hours following melatonin/placebo administration	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No