The effect on an antidote to morphine on skin sensitivity around a heat injury

• Conditions: First degree burn injury in healthy volunteers; MedDRA version: 14.1Level: LLTClassification code 10020573Term: HyperalgesiaSystem Organ Class: 100000004852; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2012-005663-27-DK
• Lead Sponsor: HOC, Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-27
• Last Update Posted: 23 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

male, healthy, age between 20 and 35, BMI between 18 and 30, verbal and written informed consent, normal cardiac ultrasound examination, normal ECG
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 49
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

unable to cooperate, not able to understand Danish or English, neurological disease, psychiatric disease, drug or alcohol abuse, chronic pain state, positive urine test for opioids (morphine, methadone, buprenorphine), skin infection in the test areas (lower leg), allergy to morphine-related drugs, chronic pain medication.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified