EUCTR2013-001540-60-DK
Active, not recruiting
Phase 1
A novel approach to assess gastrointestinal adverse effects of opioids
Mech-Sense, Aalborg University Hospital0 sitesAugust 1, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Opioid-induced bowel dysfunction.
- Sponsor
- Mech-Sense, Aalborg University Hospital
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent.
- •Able to read and understand Danish.
- •Male of Northern European descent (in order to minimize genetic variance in the study population).
- •The researcher believes that the subject understands the study details, is compliant and is expected to complete the study.
- •Opioid naïve
- •Between 20 and 60 years of age.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 70
Exclusion Criteria
- •Known allergy towards pharmaceutical compounds similar to those used in the study.
- •Participation in other studies within 14 days prior to first visit.
- •Expected need of medical/surgical treatment during the course of the study.
- •Any disease, which investigator concludes will affect the trial.
- •History of substance abuse.
- •Family history of substance abuse.
- •Daily alcohol consumption
- •Daily nicotine consumption (e.g. cigarette smoking, nicotine patch, etc.).
- •Need to operate motor vehicle within the study periods.
- •Metal implants or pacemaker.
Outcomes
Primary Outcomes
Not specified
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