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| ID | Type | Description | Link |
|---|---|---|---|
| 17352 | Other Identifier | Office of Research Ethics, UWO |
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This study consists of a series of prospective, randomized placebo-controlled n of 1 trials to objectively evaluate the reproducibility of subjective and objective symptoms among patients with a history of statin-related myopathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Statin | Experimental | Individual-specific statin causing myopathy - i.e., Patients will receive the specific statin previously associated with myopathic symptoms in them (can be any of the following statins: rosuvastatin, atorvastatin, simvastatin, fluvastatin, pravastatin in any of the doses causing symptoms previously). |
|
| Placebo | Placebo Comparator | Identical placebo to patient-specific statin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individual-specific statin causing myopathy | Drug | Individual-specific statin causing myopathy vs. placebo |
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| Measure | Description | Time Frame |
|---|---|---|
| To assess the reliability and reproducibility of subjective symptoms of myalgias to active statin therapy. | Duration of study September 2010 to August 2013 |
| Measure | Description | Time Frame |
|---|---|---|
| To delineate the relation of objective changes in non-invasive neuromuscular testing to subjective symptoms during the first exposure to active or placebo therapy, in subset of 5 patients with prior history of statin myopathy. | September 2010 to August 2013 |
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Inclusion Criteria:
Exclusion Criteria:
Subset of 5 patients also completing neuromuscular testing:
Inclusion Criteria:
- same as above
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tisha Joy, MD, FRCPC | St. Joseph's Health Care, UWO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Health Care | London | Ontario | N6A 4V2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24737272 | Derived | Joy TR, Monjed A, Zou GY, Hegele RA, McDonald CG, Mahon JL. N-of-1 (single-patient) trials for statin-related myalgia. Ann Intern Med. 2014 Mar 4;160(5):301-10. doi: 10.7326/M13-1921. |
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| Placebo | Drug | Placebo |
|