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CompletedNCT00647127Updated Sep 14, 2012

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

A Phase 3 interventional study of Buprenorphine and Fentanyl in Pain, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-09-14.

Sponsored by University of Aarhus · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Pain

Keywords

  • Buprenorphine
  • Fentanyl
  • Analgesic effect
  • Anti-hyperalgesic effect
  • Experimental pain
03

In context

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • written informed consent
  • men > 18 years

Exclusion criteria

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
05

Study design

Phase
Phase 3
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
22 participants (actual)

Study arms

  • Active comparator
    Buprenorphine

    Drug: Buprenorphine

  • Active comparator
    Fentanyl

    Drug: Fentanyl

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugBuprenorphine

    Buprenorphine: 20microg/h

    Also known as: Norspan

  • DrugFentanyl

    Fentanyl: 25microg/h

    Also known as: Durogesic

  • DrugPlacebo

    Placebo: '5microg/h' (not active drug, it is just called '5microg/h')

    Also known as: Norspan

06

What researchers measure

Primary outcomes

  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

07

Study locations

1 site
  • Mech Sense, Department of Gastroenterology
    Aalborg, Region Nordjyllan 9000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00647127
Lead sponsor
University of Aarhus
Responsible party
Sponsor
First posted
Mar 31, 2008
Start date
Feb 2008
Primary completion
Aug 2009
Completion
Jan 2010
Last update
Sep 14, 2012

Study contacts

Asbjoern M Drewes, MD, Prof.
principal investigator · Mech Sense, Department of Gastroenterology, Aalborg Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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