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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2009 by University of Aarhus. Recruitment status was Recruiting

First Received on March 26, 2008. Last Updated on 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:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator)
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
Active Comparator: 1	Drug: Buprenorphine Buprenorphine: 20microg/h Other Name: Norspan
Active Comparator: 2	Drug: Fentanyl Fentanyl: 25microg/h Other Name: Durogesic
Placebo Comparator: 3	Drug: Placebo Placebo: '5microg/h' (not active drug, it is just called '5microg/h') Other Name: Norspan

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
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:	Asbjørn M. Drewes, Professor, Dr. Med., Department of Medical Gastroenterology, Aalborg Hospital, Denmark
ClinicalTrials.gov Identifier:	NCT00647127 History of Changes
Other Study ID Numbers:	2007-004524-21
Study First Received:	March 26, 2008
Last Updated:	October 20, 2009
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:

Analgesics
Buprenorphine
Fentanyl
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on February 09, 2012