Investigation of Analgesic and Anti-Hyperalgesic Effect of Opioids in Experimental Pain - Full Text View

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

This study is currently recruiting participants.
Verified by University of Aarhus, October 2008

Sponsored by:	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

Drug Information available for:

Fentanyl Citrate Fentanyl Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment

Official Title:	Investigation of Analgesic and Anti-Hyperalgesic Effect of Opioids in Experimental Pain

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:	August 2009
Estimated Primary Completion Date:	March 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

Responsible Party:	Department of Medical Gastroenterology, Aalborg Hospital, Denmark ( Asbjørn M. Drewes, Professor, Dr. Med. )
Study ID Numbers:	2007-004524-21
First Received:	March 26, 2008
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00647127
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

Study placed in the following topic categories:

Buprenorphine

Fentanyl

Pain

Additional relevant MeSH terms:

Anesthetics, Intravenous

Physiological Effects of Drugs

Narcotic Antagonists

Anesthetics

Central Nervous System Depressants

Narcotics

Pharmacologic Actions

Adjuvants, Anesthesia

Anesthetics, General

Sensory System Agents

Therapeutic Uses

Analgesics

Peripheral Nervous System Agents

Central Nervous System Agents

Analgesics, Opioid

ClinicalTrials.gov processed this record on December 03, 2008