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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Mech Sense, Department of Gastroenterology

Aalborg, Region Nordjyllan, 9000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buprenorphine

Drug

Buprenorphine: 20microg/h

Other names: Norspan

Fentanyl

Drug

Fentanyl: 25microg/h

Other names: Durogesic

Placebo

Drug

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

Other names: Norspan

Primary outcomes

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.

Time frame: Continuously

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2010
First posted: Mar 31, 2008
Registry last updated: Sep 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed