Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine (PASORII)

This study has been completed.
Sponsor:
Collaborator:
Norpharma A/S
Information provided by (Responsible Party):
mads u werner, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01296334
First received: February 14, 2011
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

Tissue injury is associated with pain from the injured site (primary hyperalgesia) and pain from non-injured tissue in the vicinity of the trauma (secondary hyperalgesia). In the present study we investigate primary and secondary hyperalgesia in healthy volunteers following an experimental first degree burn injury.

The objectives are:

  • to compare analgesic and anti-hyperalgesic effects of two opioids (morphine and buprenorphine).
  • to investigate if these effects are related to the volunteers individual pain sensitivity

Condition Intervention
Pain
Drug: morphine
Drug: Morphine
Drug: Buprenorphine
Other: saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine Following an Experimental Inflammatory Injury in Volunteers.

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Analgesic and antihyperalgesic effects [ Time Frame: 0 min after a first degree burn injury ] [ Designated as safety issue: No ]
    Analgesic effect is assessed by change in primary hyperalgesia (pain rating [VAS]) Antihyperalgesic effect is assessed by reduction in area of hyperalgesia (sq. cm) VAS-area under curve is calculated for 0, 60, 120 and 180 min after first degree burn injury

  • Analgesic and antihyperalgesic effects [ Time Frame: 60 min after first degree burn injury ] [ Designated as safety issue: No ]
    Analgesic effect is assessed by change in primary hyperalgesia (pain rating [VAS]) Antihyperalgesic effect is assessed by reduction in area of hyperalgesia (sq. cm) VAS-area under curve is calculated for 0, 60, 120 and 180 min after first degree burn injury.

  • Analgesic and antihyperalgesic effects [ Time Frame: 120 min after first degree burn injury ] [ Designated as safety issue: No ]
    Analgesic effect is assessed by change in primary hyperalgesia (pain rating [VAS]) Antihyperalgesic effect is assessed by reduction in area of hyperalgesia (sq. cm) VAS-area under curve is calculated for 0, 60, 120 and 180 min after first degree burn injury

  • Analgesic and antihyperalgesic effects [ Time Frame: 180 min after first degree burn injury ] [ Designated as safety issue: No ]
    Analgesic effect is assessed by change in primary hyperalgesia (pain rating [VAS]) Antihyperalgesic effect is assessed by reduction in area of hyperalgesia (sq. cm) VAS-area under curve is calculated for 0, 60, 120 and 180 min after first degree burn injury


Secondary Outcome Measures:
  • Difference in analgesic/antihyperalgesic profile between pain-sensitive and pain-non-sensitive individuals [ Time Frame: 0-180 min after first degree burn injury ] [ Designated as safety issue: No ]
    The ratios between areas under curve (0-180 min after first degree burn injury) for analgesic effect assessed by change in primary hyperalgesia (pain rating VAS])and antihyperalgesic effect assessed by reduction in area of hyperalgesia (sq. cm).


Enrollment: 34
Study Start Date: February 2011
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: morphine low dose Drug: morphine
intravenous infusion, 10 mg, once, 4 hours
Experimental: morphine high dose Drug: Morphine
intravenous infusion, 20 mg, once, 4 hours
Experimental: buprenorphine low dose Drug: Buprenorphine
intravenous infusion, 0.3 mg, once, 4 hours
Experimental: buprenorphine high dose Drug: Buprenorphine
intravenous infusion, 0.6 mg, once, 4 hours
Placebo Comparator: placebo Other: saline
intravenous infusion, 0.9% saline, once, 4 hours

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy individuals
  • adequate psychomotor performance to perform pain tests
  • pain-sensitive or pain-nonsensitive according to prespecified criteria

Exclusion Criteria:

  • known allergy to morphine or buprenorphine
  • prior adverse experiences with opioids
  • history of abuse
  • females not taking P-pills
  • skin lesions on the test-sites
  • suffering from chronic pain
  • medication with analgesics
  • BMI > 28
  • smoker
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296334

Locations
Denmark
Zelo Phase One Clinical Trial Unit, Bispebjerg Hospital
Copenhagen NV, Denmark, 2400
Sponsors and Collaborators
mads u werner
Norpharma A/S
Investigators
Study Director: Mads U Werner, MD, DMSc Multidisciplinary Pain Centre 7612, Rigshospitalet, Blegdamsvej 9, DK 2100 Copenhagen O
Study Chair: Lona L Christrup, MSc , PhD Pharmaceutical Faculty, Copenhagen University
  More Information

Publications:
Responsible Party: mads u werner, MD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01296334     History of Changes
Other Study ID Numbers: H-2-2010-115, 2010-022903-23
Study First Received: February 14, 2011
Last Updated: February 4, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Medicines Agency

Keywords provided by University of Copenhagen:
opioids
analgesia
secondary hyperalgesia
quantitative sensory testing
inflammatory injury

Additional relevant MeSH terms:
Analgesics
Buprenorphine
Morphine
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Narcotic Antagonists

ClinicalTrials.gov processed this record on August 28, 2014