The effect of tapentadol and oxycodone on the human pain system

Phase 1

• Conditions: Healthy volunteers - pain; MedDRA version: 20.1Level: LLTClassification code 10049475Term: Chronic painSystem Organ Class: 100000004867; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-000141-52-DK
• Lead Sponsor: Asbjørn Mohr Drewes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-10
• Study Completion: 2019-05-09
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 22

Inclusion Criteria

•Signed informed consent before any study specific procedures
•Able to read and understand Danish.
•The researcher believes that the participant understands what the study entails, are capable of following instructions, are able to attend when needed, are expected to complete the study
•Male
•Between 20 and 45 years of age
•Scandinavian descent
•Healthy
•Opioid naïve subjects (who have not taken opioid doses for 1 week or longer)

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

••Female
•Known allergy towards pharmaceutical compounds similar to those used in the study
•Participation in other studies within 14 days of first visit
•Expected need of medical/surgical treatment during the course of the study
•History of psychiatric illness
•History of persistent or recurring pain conditions
•Nicotine consumption
•Daily alcohol consumption
•History of substance abuse
•Family history of substance abuse
•Use of any analgesic medication within 48 hours before start as well as for the duration of the study period
•Use of any medication (herbal as well as any over-the-counter drugs) within 48 hours before start of the study period
•Intake of alcohol within 24 hours before start of the study period
•Use of prescription medicine and/or herbal medicine
•Need to drive motor vehicle within the treatment periods
•Severe respiratory depression
•Increased intracranial pressure
•Paralytic ileus
•Severe decreased renal or hepatic function
•Treatment with MAO-inhibitors
•Cor pulmonale
•Severe COPD or acute severe asthma

Study & Design

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