Investigation of Analgesic and Anti-hyperalgesic Effect of Opioids in Experimental Pain

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00647127

Enrollment

Registered

2008-03-31

Start date

2008-02-29

Completion date

2010-01-31

Last updated

2012-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Buprenorphine, Fentanyl, Analgesic effect, Anti-hyperalgesic effect, Experimental pain

Brief summary

To compare the analgesic and anti-hyperalgesic effect of Buprenorphine and Fentanyl against experimental pain in skin, muscle and bone. The study will be performed with healthy volunteers.

Interventions

DRUGBuprenorphine

Buprenorphine: 20microg/h

DRUGFentanyl

Fentanyl: 25microg/h

DRUGPlacebo

Placebo: '5microg/h' (not active drug, it is just called '5microg/h')

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* written informed consent * men \> 18 years

Exclusion criteria

* women * known allergy against the investigated drugs * ongoing participation in other experiments or participation in other experiments 14 days before screening * previously pain or psychiatric conditions * simultaneously use of pain killers * alcohol * previously drug-addict or member of family with drug-addicts * chronic constipation * ileus * inflammatory bowel syndrome * abdominal surgery within the last three months

Design outcomes

Primary

Measure	Time frame
Data will be electronically recorded or written directly in case report form. Outcome measure will be a subjective rating of the pain with a visual analogue scale.	Continuously

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026