EUCTR2016-002081-31-DK
Active, not recruiting
Phase 1
Investigation of dose response relationships when using low dose naltrexone (LDN) for the treatment of fibromyalgia
Anæstesiologisk-intensiv afd V, Odense Universitets Hospital0 sites38 target enrollmentOctober 6, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- Anæstesiologisk-intensiv afd V, Odense Universitets Hospital
- Enrollment
- 38
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with fibromyalgia by a rheumatologist
- •Fullfils ACR 1990 og 2010 criteria for fibromyalgia
- •Use of anti conception
- •Speaks and writes danish
- •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 38
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range 0
Exclusion Criteria
- •Other concomitant pain disease
- •Suicidal attempts within 5 years
- •Suicida ideation
- •Severe psychiatric disease
- •Allergy against naltrexon
- •Abuse of alcohol or other substances
- •Use of opioid within 8 weeks
Outcomes
Primary Outcomes
Not specified
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