Pain Clinical Trial
Official title:
Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms
This study will evaluate whether a dietary supplement, coenzyme Q10 (CoQ10), will improve muscle symptoms, such as muscle aches, pains, cramps, and/or weakness, which are experienced by some individuals who use statin medications.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | December 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - Patients with a history of muscle symptoms (such as aches, pains, cramps and/or weakness) while taking a statin drug that persisted for at least 2 weeks on a statin Exclusion Criteria: - Plasma creatine kinase levels > 3 times the upper normal limit - Liver enzymes, alanine transferase (ALT) or aspartate transferase (AST) > 2 times the upper normal limit - Pregnancy or breastfeeding (a contraindication for statin use) - Severe renal impairment, defined as glomerular filtration rate (GFR) < 30 ml/min/1.73 m2 - Bleeding disorder, current use of warfarin, an international normalized ratio (INR) greater than 1.5, or a platelet count less than 100,000 mm3 - Contraindication to strength testing, including myocardial infarction, unstable angina, or revascularization procedure within the past six weeks, a history of brain aneurysm or stroke - Chest or abdominal surgery within the past six weeks - Severe persistent pain related to other causes - Unable to complete self-administered questionnaires, or unable to read or converse in English |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Catherine Buettner | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Muscle symptoms | 4 weeks | No | |
Secondary | Continued statin use | 4 weeks | No | |
Secondary | Muscle strength | 4 weeks | No | |
Secondary | Disability | 4 weeks | No | |
Secondary | Adverse effects | 4 weeks | Yes |
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