The Analgesic Effects of Melatonin

Lars Peter Holst Andersen

Status and phase: Completed; Phase 3; Phase 2

Conditions: Antihyperalgesia; Analgesia

Treatments: Drug: Melatonin 10 mg; Drug: Melatonin 100 mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01923974

CPO-2013

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

IV formulation

Treatment:

Drug: Placebo

Melatonin 10 mg

Active Comparator group

Description:

IV formulation, Melatonin 10 mg

Treatment:

Drug: Melatonin 10 mg

Melatonin 100 mg

Active Comparator group

Description:

IV formulation, Melatonin 100 mg

Treatment:

Drug: Melatonin 100 mg