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

This study is currently recruiting participants.

Verified by University of Aarhus, October 2009

First Received: March 26, 2008 Last Updated: October 20, 2009 History of Changes

Sponsor:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00647127

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: Buprenorphine Drug: Fentanyl Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment
Official Title:	Investigation of Analgesic and Anti-hyperalgesic Effect of Opioids in Experimental Pain

Resource links provided by NLM:

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Fentanyl Fentanyl Citrate

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	February 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Buprenorphine Buprenorphine: 20microg/h
2: Active Comparator	Drug: Fentanyl Fentanyl: 25microg/h
3: Placebo Comparator	Drug: Placebo Placebo: '5microg/h' (not active drug, it is just called '5microg/h')

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647127

Locations

Denmark, Region Nordjyllan
Mech Sense, Department of Gastroenterology	Recruiting
Aalborg, Region Nordjyllan, Denmark, 9000
Contact: Asbjørn M Drewes, Prof., MD +45 99326228 drewes@hst.aau.dk
Contact: Trine Andresen, MSc. (pharm) +45 99326243 tan@hst.aau.dk
Principal Investigator: Asbjørn M Drewes, Prof., MD

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator:

Asbjoern M Drewes, MD, Prof.

Mech Sense, Department of Gastroenterology, Aalborg Hospital

More Information

No publications provided

Responsible Party:	Department of Medical Gastroenterology, Aalborg Hospital, Denmark ( Asbjørn M. Drewes, Professor, Dr. Med. )
Study ID Numbers:	2007-004524-21
Study First Received:	March 26, 2008
Last Updated:	October 20, 2009
ClinicalTrials.gov Identifier:	NCT00647127 History of Changes
Health Authority:	Denmark: Danish Medicines Agency; Denmark: Ethics Committee; Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:

Buprenorphine
Fentanyl
Analgesic effect
Anti-hyperalgesic effect
Experimental pain

Additional relevant MeSH terms:

Anesthetics, Intravenous
Fentanyl
Physiological Effects of Drugs
Narcotic Antagonists
Anesthetics
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia

Buprenorphine
Anesthetics, General
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 27, 2009