FibromyalgiaPhase 2NCT00272207
A Trial Assessing the Effect of Nabilone on Pain and Quality of Life in Patients With Fibromyalgia
A Phase 2 study testing Nabilone in people with Fibromyalgia, run by Winnipeg Regional Health Authority at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Nabilone
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2006to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double-blinded Placebo Controlled Trial Assessing the Effect of the Oral Cannabinoid Nabilone on Pain and Quality of Life in Patients With Fibromyalgia
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.
Read the 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% of the general population, affecting females more commonly than males. Symptoms usually start between 20 and 55 years of age.
No medical treatment has been specifically approved for the management of fibromyalgia, however, there is strong evidence that some antidepressants, exercise, and patient education are effective in reducing the pain experienced by fibromyalgia patients. A recent study of four patients has suggested the possible benefit of Nabilone, a synthetic cannabinoid, in the treatment of fibromyalgia, however more studies are needed.
Marijuana is the common name for cannabis. Nabilone (brand name, CESAMET®), is a synthetic cannabinoid (form of cannabis). Cannabinoid receptors exist naturally in the human body and respond to naturally occurring cannabinoids produced by the body, as well as marijuana and synthetic cannabinoids like Nabilone.
In Canada, Nabilone is approved for the treatment and management of severe nausea and vomiting associated with cancer chemotherapy and may be prescribed by physicians.
Research has shown that activating the cannabinoid receptors also has an effect on reducing acute and chronic pain.
Our hypothesis is that the synthetic cannabinoid Nabilone will significantly reduce the pain experienced by patients with fibromyalgia and improve quality of life, compared to the placebo controlled group. This will be evident by finding significant differences in Visual Analogue Scale pain scores, number of tender points, average pain threshold, and scores on the Fibromyalgia Impact Questionaire.
- Conditions
- Fibromyalgia
- Being tested
- Nabilone
- Keywords
- Fibromyalgia, Cannabinoids, Nabilone, Cesamet, Pain
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NabiloneDrug
Also called Cesamet
Oral nabilone, 0.5 mg x7 days, increased to 0.5 mg t.i.d x 2 weeks if patient tolerates, then increase if patient tolerating to 0.5 in am and 1.0 mg at hs x 1 week, then if patient tolerating, increase to 1.0 mg b.i.d x 1 week.
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale Pain Scores
Patient is asked to mark their pain from 0 to 10, with 0 = no pain, and 10 = worst pain imaginable
Measured: Baseline, then at week 2, 4 and 8
Number of Tender Points
Physician examines by digital palpation for pain at each of the 18 characteristic tender points for fibromyalgia. The number of tender points where pain is reported is recorded
Measured: At baseline, then at the week 2, 4 and 8 visits
Average Pain Threshold
Patients are examined for pain at the 18 characteristic tender points. The results of all the sites are added and divided by 18 to give an average pain threshold
Measured: At baseline, then at the 2, 4 and 8 week visits
Fibromyalgia Impact Questionaire
Self-administered questionnaire that evaluates physical function, work status, depression anxiety, sleep, pain, stiffness, fatigue and well-being.
Measured: At baseline, then again at weeks 2, 4 and 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startApr 2006
- Primary completionFeb 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winnipeg Regional Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Valeant Canada Limited
- Responsible party
- Principal investigator, Dr. Lena Galimova, Winnipeg Regional Health Authority
- Investigators
- Lena Galimova, MD, Principal investigator, The Royal College of Physicians and Surgeons of CanadaRyan Skrabek, MD, Study chair, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272207
- Sponsor's protocol ID
- WPG2005#1974
- Status last verified
- Aug 2011
- First submitted
- 3 Jan 2006
- Last updated
- 25 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blinded Placebo Controlled Trial Assessing the Effect of the Oral Cannabinoid Nabilone on Pain and Quality of Life in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT00272207
- Acronym / sponsor ID
- WPG2005#1974
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Cannabinoids, Nabilone, Cesamet, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Winnipeg Regional Health AuthorityUniversity, hospital or other
- Collaborators
- Valeant Canada Limited
- Study start
- Apr 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 4 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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% of the general population, affecting females more commonly than males. Symptoms usually start between 20 and 55 years of age.
No medical treatment has been specifically approved for the management of fibromyalgia, however, there is strong evidence that some antidepressants, exercise, and patient education are effective in reducing the pain experienced by fibromyalgia patients. A recent study of four patients has suggested the possible benefit of Nabilone, a synthetic cannabinoid, in the treatment of fibromyalgia, however more studies are needed.
Marijuana is the common name for cannabis. Nabilone (brand name, CESAMET®), is a synthetic cannabinoid (form of cannabis). Cannabinoid receptors exist naturally in the human body and respond to naturally occurring cannabinoids produced by the body, as well as marijuana and synthetic cannabinoids like Nabilone.
In Canada, Nabilone is approved for the treatment and management of severe nausea and vomiting associated with cancer chemotherapy and may be prescribed by physicians.
Research has shown that activating the cannabinoid receptors also has an effect on reducing acute and chronic pain.
Our hypothesis is that the synthetic cannabinoid Nabilone will significantly reduce the pain experienced by patients with fibromyalgia and improve quality of life, compared to the placebo controlled group. This will be evident by finding significant differences in Visual Analogue Scale pain scores, number of tender points, average pain threshold, and scores on the Fibromyalgia Impact Questionaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NabiloneAlso: CesametOral nabilone, 0.5 mg x7 days, increased to 0.5 mg t.i.d x 2 weeks if patient tolerates, then increase if patient tolerating to 0.5 in am and 1.0 mg at hs x 1 week, then if patient tolerating, increase to 1.0 mg b.i.d x 1 week. | Drug | – |
Primary outcome
Visual Analogue Scale Pain Scores
Time frame: Baseline, then at week 2, 4 and 8
Patient is asked to mark their pain from 0 to 10, with 0 = no pain, and 10 = worst pain imaginable
Number of Tender Points
Time frame: At baseline, then at the week 2, 4 and 8 visits
Physician examines by digital palpation for pain at each of the 18 characteristic tender points for fibromyalgia. The number of tender points where pain is reported is recorded
Average Pain Threshold
Time frame: At baseline, then at the 2, 4 and 8 week visits
Patients are examined for pain at the 18 characteristic tender points. The results of all the sites are added and divided by 18 to give an average pain threshold
Fibromyalgia Impact Questionaire
Time frame: At baseline, then again at weeks 2, 4 and 8.
Self-administered questionnaire that evaluates physical function, work status, depression anxiety, sleep, pain, stiffness, fatigue and well-being.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena Galimova, MD principal investigator
The Royal College of Physicians and Surgeons of Canada
Ryan Skrabek, MD study chair
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nabilone in people with Fibromyalgia, run by Winnipeg Regional Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale Pain Scores (time frame: Baseline, then at week 2, 4 and 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2011.