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

March 26, 2008
September 13, 2012
February 2008
August 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00647127 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Investigation of Analgesic and Anti-hyperalgesic Effect of Opioids in Experimental Pain
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Pain
  • Drug: Buprenorphine
    Buprenorphine: 20microg/h
    Other Name: Norspan
  • Drug: Fentanyl
    Fentanyl: 25microg/h
    Other Name: Durogesic
  • Drug: Placebo
    Placebo: '5microg/h' (not active drug, it is just called '5microg/h')
    Other Name: Norspan
  • Active Comparator: Buprenorphine
    Intervention: Drug: Buprenorphine
  • Active Comparator: Fentanyl
    Intervention: Drug: Fentanyl
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
January 2010
August 2009   (final data collection date for primary outcome measure)

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
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00647127
2007-004524-21
Yes
University of Aarhus
University of Aarhus
Not Provided
Principal Investigator: Asbjoern M Drewes, MD, Prof. Mech Sense, Department of Gastroenterology, Aalborg Hospital
University of Aarhus
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP