Investigation of Analgesic and Anti-Hyperalgesic Effect of Opioids in Experimental Pain - Tabular View

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

This study is currently recruiting participants.

Study NCT00647127. Last updated on October 24, 2008. Information provided by University of Aarhus

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Other, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment

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 ]

Secondary Outcome Measure ^†

Condition ^†

Pain

Intervention ^†

Drug: Buprenorphine
Drug: Fentanyl
Drug: Placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

February 2008

Completion Date

August 2009

Eligibility 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

Gender

Male

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Denmark

Administrative Information Fields

NCT ID ^†

NCT00647127

Organization ID

2007-004524-21

Secondary IDs ^††

Study Sponsor ^†

University of Aarhus

Collaborators ^††

Investigators ^†

Principal Investigator:

Asbjoern M Drewes, MD, Prof.

Mech Sense, Department of Gastroenterology, Aalborg Hospital

Information Provided By

University of Aarhus

Verification Date

October 2008

First Received Date ^†

March 26, 2008

Last Updated Date

October 24, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.