Status:
COMPLETED
A Trial Assessing the Effect of Nabilone on Pain and Quality of Life in Patients With Fibromyalgia
Lead Sponsor:
Winnipeg Regional Health Authority
Collaborating Sponsors:
Valeant Canada Limited
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine whether or not the drug Nabilone significantly reduces pain and improves quality of life in patients with fibromyalgia.
Detailed Description
Fibromyalgia is a disease of unknown cause. People with fibromyalgia experience diffuse body pain, fatigue, sleep disturbance, and a generalized stiffness and swollen feeling. Fibromyalgia affects 2-6...
Eligibility Criteria
Inclusion
- The patient meets The American College of Rheumatology (1990) criteria for the classification of fibromyalgia. \[5\]
- 18-70 years old.
- Any gender.
- The patient has not received benefit from a tricyclic antidepressant, muscle relaxant, acetaminophen or non-steroidal anti-inflammatories for management of their pain.
- No previous use of oral cannabinoids for pain management.
Exclusion
- The patient's pain is better explained by a diagnosis other then fibromyalgia.
- Abnormalities on routine baseline blood work including electrolytes, urea and creatinine, a complete blood count, and liver function tests (AST ALT GGT, Alk Phos, and LDH). Normal tests taken within 3 months prior to the study will be accepted if there is no history of acute illness since the time the blood was drawn.
- Heart disease. (Cannabinoids can reduce heart rate and blood pressure) Patients with heart disease will be excluded based on a history of angina, MI or CHF as well as a clinical exam.
- Schizophrenia or other Psychotic disorder
- Severe liver dysfunction. (Patients will be excluded if there is an elevation of any of the baseline liver enzymes)
- History of untreated non-psychotic emotional disorders.
- Cognitive impairment.
- Major illness in another body area.
- Pregnancy.
- Nursing mothers.
- Patients less than 18 years old.
- History of drug dependency.
- A known sensitivity to marijuana or other cannabinoid agents
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00272207
Start Date
April 1 2006
End Date
March 1 2007
Last Update
August 25 2011
Active Locations (1)
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1
Rehabilitation Hospital
Winnipeg, Manitoba, Canada, R3A 1M4