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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00647127
Recruitment Status : Completed
First Posted : March 31, 2008
Last Update Posted : September 14, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Pain Drug: Buprenorphine Drug: Fentanyl Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Investigation of Analgesic and Anti-hyperalgesic Effect of Opioids in Experimental Pain
Study Start Date : February 2008
Primary Completion Date : August 2009
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00647127     History of Changes
Other Study ID Numbers: 2007-004524-21
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: September 14, 2012
Last Verified: September 2012

Keywords provided by University of Aarhus:
Buprenorphine
Fentanyl
Analgesic effect
Anti-hyperalgesic effect
Experimental pain

Additional relevant MeSH terms:
Fentanyl
Buprenorphine
Analgesics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Narcotic Antagonists