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Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine

NCT ID: NCT01296334

Last Updated: 2016-11-28

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

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-10-31

Brief Summary

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Tissue injury is associated with pain from the injured site (primary hyperalgesia) and pain from non-injured tissue in the vicinity of the trauma (secondary hyperalgesia). In the present study we investigate primary and secondary hyperalgesia in healthy volunteers following an experimental first degree burn injury.

The objectives are:

* to compare analgesic and anti-hyperalgesic effects of two opioids (morphine and buprenorphine).
* to investigate if these effects are related to the volunteers individual pain sensitivity

Detailed Description

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Please refer to:

Ravn P, Secher EL, Skram U, Therkildsen T, Christrup LL, Werner MU (2013) Morphine- and buprenorphine-induced analgesia and antihyperalgesia in a human inflammatory pain model: a double-blind, randomized, placebo-controlled, five-arm crossover study. J Pain Res 6: 23-38. 10.2147/JPR.S36827 \[doi\];jpr-6-023 \[pii\].

Conditions

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Pain

Keywords

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opioids analgesia secondary hyperalgesia quantitative sensory testing inflammatory injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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morphine low dose

morphine infusion 10 mg over a 210 min period

Group Type EXPERIMENTAL

morphine LO

Intervention Type DRUG

intravenous infusion, 10 mg, once, 4 hours

morphine high dose

morphine infusion 20 mg over a 210 min period

Group Type EXPERIMENTAL

Morphine Hi

Intervention Type DRUG

intravenous infusion, 20 mg, once, 4 hours

buprenorphine low dose

buprenorphine infusion 0.3 mg over a 210 min period

Group Type EXPERIMENTAL

Buprenorphine LO

Intervention Type DRUG

intravenous infusion, 0.3 mg, once, 4 hours

buprenorphine high dose

buprenorphine infusion 0.6 mg over a 210 min period

Group Type EXPERIMENTAL

Buprenorphine Hi

Intervention Type DRUG

intravenous infusion, 0.6 mg, once, 4 hours

placebo

placebo (normal saline) infusion 0.6 mg over a 210 min period

Group Type PLACEBO_COMPARATOR

saline

Intervention Type OTHER

intravenous infusion, 0.9% saline, once, 4 hours

Interventions

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morphine LO

intravenous infusion, 10 mg, once, 4 hours

Intervention Type DRUG

Morphine Hi

intravenous infusion, 20 mg, once, 4 hours

Intervention Type DRUG

Buprenorphine LO

intravenous infusion, 0.3 mg, once, 4 hours

Intervention Type DRUG

Buprenorphine Hi

intravenous infusion, 0.6 mg, once, 4 hours

Intervention Type DRUG

saline

intravenous infusion, 0.9% saline, once, 4 hours

Intervention Type OTHER

Other Intervention Names

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Morfin SAD Morfin SAD Temgesic Temgesic 0.9% NaCl

Eligibility Criteria

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Inclusion Criteria

* healthy individuals
* adequate psychomotor performance to perform pain tests
* pain-sensitive or pain-nonsensitive according to prespecified criteria

Exclusion Criteria

* known allergy to morphine or buprenorphine
* prior adverse experiences with opioids
* history of abuse
* females not taking P-pills
* skin lesions on the test-sites
* suffering from chronic pain
* medication with analgesics
* BMI \> 28
* smoker
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Norpharma A/S

INDUSTRY

Sponsor Role collaborator

mads u werner

OTHER

Sponsor Role lead

Responsible Party

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mads u werner

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mads U Werner, MD, DMSc

Role: STUDY_DIRECTOR

Multidisciplinary Pain Centre 7612, Rigshospitalet, Blegdamsvej 9, DK 2100 Copenhagen O

Lona L Christrup, MSc, PhD

Role: STUDY_CHAIR

Pharmaceutical Faculty, Copenhagen University

Locations

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Zelo Phase One Clinical Trial Unit, Bispebjerg Hospital

Copenhagen NV, , Denmark

Site Status

Countries

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Denmark

References

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Koppert W, Ihmsen H, Korber N, Wehrfritz A, Sittl R, Schmelz M, Schuttler J. Different profiles of buprenorphine-induced analgesia and antihyperalgesia in a human pain model. Pain. 2005 Nov;118(1-2):15-22. doi: 10.1016/j.pain.2005.06.030. Epub 2005 Sep 9.

Reference Type BACKGROUND
PMID: 16154698 (View on PubMed)

Ravn P, Secher EL, Skram U, Therkildsen T, Christrup LL, Werner MU. Morphine- and buprenorphine-induced analgesia and antihyperalgesia in a human inflammatory pain model: a double-blind, randomized, placebo-controlled, five-arm crossover study. J Pain Res. 2013;6:23-38. doi: 10.2147/JPR.S36827. Epub 2013 Jan 9.

Reference Type RESULT
PMID: 23359655 (View on PubMed)

Other Identifiers

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2010-022903-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

H-2-2010-115

Identifier Type: -

Identifier Source: org_study_id