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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00647127
First received: March 26, 2008
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  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 3

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:

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 ]

Enrollment: 22
Study Start Date: February 2008
Study Completion Date: January 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Buprenorphine Drug: Buprenorphine
Buprenorphine: 20microg/h
Other Name: Norspan
Active Comparator: Fentanyl Drug: Fentanyl
Fentanyl: 25microg/h
Other Name: Durogesic
Placebo Comparator: Placebo 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
Aalborg, Region Nordjyllan, Denmark, 9000
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: University of Aarhus
ClinicalTrials.gov Identifier: NCT00647127     History of Changes
Other Study ID Numbers: 2007-004524-21
Study First Received: March 26, 2008
Last Updated: September 13, 2012
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 May 16, 2013