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

NCT ID: NCT00647127

Last Updated: 2012-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-01-31

Brief Summary

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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

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Conditions

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Pain

Keywords

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Buprenorphine Fentanyl Analgesic effect Anti-hyperalgesic effect Experimental pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Buprenorphine

Group Type ACTIVE_COMPARATOR

Buprenorphine

Intervention Type DRUG

Buprenorphine: 20microg/h

Fentanyl

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Fentanyl: 25microg/h

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Buprenorphine

Buprenorphine: 20microg/h

Intervention Type DRUG

Fentanyl

Fentanyl: 25microg/h

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Norspan Durogesic Norspan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Asbjoern M Drewes, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Mech Sense, Department of Gastroenterology, Aalborg Hospital

Locations

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Mech Sense, Department of Gastroenterology

Aalborg, Region Nordjyllan, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2007-004524-21

Identifier Type: -

Identifier Source: org_study_id