EUCTR2015-002435-18-DK
Active, not recruiting
Phase 1
An Evidence Based, Translational, Cross-Over, Randomized, Double-Blind, Placebo Controlled Study to Evaluate Effectiveness of Topically applied Combination of Diclofenac and Methadone Gel (Diclometh) in Human Experimental Pain Models
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy volunteers
- Sponsor
- Aalborg University Hospital
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males from the ages of 18 years to 65
- •Intact skin in the area of drug application.
- •Given informed consent to participate in this study.
- •The participants must be able to read and understand Danish.
- •Participants must be willing and be able to comply with the scheduled visits and trial procedures.
- •Northern European descent (in order to minimize genetic variance influences on pain perception and drug metabolism).
- •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 21
Exclusion Criteria
- •Known hypersensitivity to methadone and/or diclofenac.
- •Neurological or psychiatric disease sufficient , in the investigators opinion, to compromise the data collection.
- •Participants with past or present history of substance abuse and/or patients using any illegal substances.
- •Use of prescription medicine and/or herbal medicine
- •Participants takingUse of over\-the\-counter medication 24 hours before and in each study period
Outcomes
Primary Outcomes
Not specified
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