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

Phase 1

• Conditions: Healthy volunteers; MedDRA version: 18.0Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-002435-18-DK
• Lead Sponsor: Aalborg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-12
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

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

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

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