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

Tracking Information

First Received Date ^ICMJE

March 26, 2008

Last Updated Date

October 20, 2009

Start Date ^ICMJE

February 2008

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00647127 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: Buprenorphine
Drug: Fentanyl
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2010

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00647127

Responsible Party

Asbjørn M. Drewes, Professor, Dr. Med., Department of Medical Gastroenterology, Aalborg Hospital, Denmark

Study ID Numbers ^ICMJE

2007-004524-21

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Asbjoern M Drewes, MD, Prof.

Mech Sense, Department of Gastroenterology, Aalborg Hospital

Information Provided By

University of Aarhus

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP