The analgesic effects of melatonin. A study on healthy volunteers

The analgesic effects of melatonin: A randomized, placebo-controlled, double-blinded study on healthy volunteers - The analgesic effects of melatonin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000205-23-DK

Enrollment

Registered

2013-03-27

Start date

2013-03-27

Completion date

Unknown

Last updated

2014-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heat injury in healthy volunteers MedDRA version: 16.0 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863 MedDRA version: 16.0 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865

Interventions

Product Name: Melatonin Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: Melatonin CAS Number: 73-31-4 Other descriptive name: MELATONIN Concentration unit:

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Healthy males aged between 20 and 40 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Under aged/minors Does not speak or understand danish Alcol/medicin abuse 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Quantitative sensory testing in the heat injury area after melatonin/placebo-treatment. 1. Pain (VAS) during heat injury and areas of hyperalgsia 2. Pharmacokinetic and pharmacodynamic variables, plasma-concentration profiles, and hysteresis-curves with plasma-concentration (during onset og off-set) vs. effekt-variables ;Secondary Objective: Erythema/oedema, and thermal and mechanical thresholds of quantitative sensory testing;Primary end point(s): Pain(VAS) during heat injury and areas of hyperalgesia ;Timepoint(s) of evaluation of this end point: Baseline + 1,2,3 hours postburn	—

Measure

Time frame

Main Objective: Quantitative sensory testing in the heat injury area after melatonin/placebo-treatment. 1. Pain (VAS) during heat injury and areas of hyperalgsia 2. Pharmacokinetic and pharmacodynamic variables, plasma-concentration profiles, and hysteresis-curves with plasma-concentration (during onset og off-set) vs. effekt-variables ;Secondary Objective: Erythema/oedema, and thermal and mechanical thresholds of quantitative sensory testing;Primary end point(s): Pain(VAS) during heat injury and areas of hyperalgesia ;Timepoint(s) of evaluation of this end point: Baseline + 1,2,3 hours postburn

—

Secondary

Measure	Time frame
Secondary end point(s): Erythema and thermal/mechanical thresholds;Timepoint(s) of evaluation of this end point: Baseline + 1,2,3 hours postburn	—

Countries

Denmark

Contacts

Public ContactLars Peter Holst Andersen

Department of surgery, Herlev Hospital

Lars.Peter.Holst.Andersen@regionh.dk004531518908

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026