Breathing effects of two opioid pain killers in healthy volunteers

Phase 1

• Conditions: Chronic pain; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2018-003515-22-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-09
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Healthy male and female volunteers 18-38 years
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 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Presence of health issues including presence or history of any psychiatric, medical or neurologic disorder that may interfere with the current study (eg. neuropathic pain conditions);
- Presence or a history of illicit drug use or excessive alcohol consumption (>21 units per week),
- Known allergies to study medication.
- A positive drug screen on the day of screening or on any of the study days,
- Participation in another trial in the 3 months before enrolment,
- Use of medication on a regular basis (e.g. pain medication),
- Inability to fast for at least 8 hours prior to study treatment administration,
- Pregnancy or lactation,
- Inability to communicate with the research team
- surgery during the study period.

Study & Design

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