The Analgesic Effects of Melatonin

October 21, 2014 updated by: Lars Peter Holst Andersen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2200
        • Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain (VAS)
Time Frame: During burn injury. 1 hours following melatonin/placebo administration
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
1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lars Peter Holst Andersen

Collaborators

University of Copenhagen

Investigators

  • Principal Investigator: Lars P.H. Andersen, MD, Herlev Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

August 15, 2013

First Posted (ESTIMATE)

August 16, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 22, 2014

Last Update Submitted That Met QC Criteria

October 21, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPO-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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