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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647127
• Other study ID #: 2007-004524-21
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2008
• Last updated: September 13, 2012
• Start date: February 2008
• Est. completion date: January 2010

Study information

• Verified date: September 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Buprenorphine
Buprenorphine: 20microg/h
• Fentanyl
Fentanyl: 25microg/h
• Placebo
Placebo: '5microg/h' (not active drug, it is just called '5microg/h')

Locations

Country	Name	City	State
Denmark	Mech Sense, Department of Gastroenterology	Aalborg	Region Nordjyllan

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Continuously	No