NCT00489684

Brief Summary

The study is a multi-modal multi-tissue human experimental pain study in 24 healthy volunteers. The study is a randomized cross-over study. The effect of 2 opioids will be compared on pain stimuli in skin, muscle an oesophagus. Hyperalgesia will be induced in skin and oesophagus, to sensitize these tissues. The pain thresholds before and after opioid administration will be compared. The hypothesis is that the difference in effect of the opioids is more pronounced in the presence of hyperalgesia. As hyperalgesia is a common phenomenon the clinic, the findings in this study may lead to a better understanding of the treatment of pain. The study will include an explorative study of the effect of Morphine of pain processing in the brain, this will provide us with new insight in the effect of the opioids of pain processing in the brain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

June 17, 2008

Status Verified

June 1, 2008

First QC Date

June 20, 2007

Last Update Submit

June 13, 2008

Conditions

Pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

  • Between 18 and 65 years
  • Signed informed concent
  • Healthy
  • Women must use a safe contraceptive method
  • Negative pregnancy test

You may not qualify if:

  • Pregnancy
  • Allergy to study medication
  • Participating in another medicine study
  • Previous addictive behaviour
  • Need for other treatments
  • Use of strong analgesics
  • Use of any analgesics 24 hours before the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenterological outpatients clinic

Aalborg, Aalborg, 9000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples are collected to study the pharmacokinetic of the drugs

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Asbjørn Mohr Drewes, Professor

    Aalborg Hospital S. Gastroenterological Outpatients clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 20, 2007

First Posted

June 21, 2007

Study Start

August 1, 2007

Study Completion

March 1, 2008

Last Updated

June 17, 2008

Record last verified: 2008-06

Locations

DK(1)