Back to resultsClinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms
Primary Purpose
Pain, Weakness, Cramps
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Coenzyme Q10
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring CoQ10, Statins, Myalgia, Muscle Pain, Muscle Weakness
Eligibility Criteria
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
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Coenzyme Q10
Placebo
Arm Description
600 mg of CoQ10 taken as 300 mg (three 100 mg wafers) two times daily. Study wafers: ChewQ (Tishcon Corp, Westbury, NY) are chewable wafers each containing 100 mg of Coenzyme Q10 (ubidecarenone USP). All participants randomized continued use of simvastatin 20 mg started during the run-in phase of the study.
Placebo was manufactured by the manufacturer of ChewQ, Tishcon Corp (Westbury, NY), included the same excipients, but no active CoQ10, and looked and tasted identical to active agent. All participants randomized continued use of simvastatin 20 mg started during the run-in phase of the study.
Outcomes
Primary Outcome Measures
Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use
Clinically significant pain reduction was defined, a priori, as a reduction > 1.5 points on the Brief Pain Inventory-Severity Scale (BPI-SS), range: 0 to 10
Secondary Outcome Measures
Continuation of Statin
Adherence of statin use was defined a priori as participant using Simvastatin 20 mg /day at the end of 4 weeks and having used >85% of statin doses.
Percentage of Participants With Improvement in Disability Related to Muscle Pain
Disability improvement was based on patient report of improvement they felt was meaningful to them
Percentage of Participants With Adverse Effects
serious adverse effects and possible side effects were tracked through all phases of the study by participant interview and checklist at each visit, up to 4 weeks.
Full Information
NCT ID
NCT01032993
First Posted
December 15, 2009
Last Updated
November 29, 2016
Sponsor
Catherine Buettner
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT01032993
Brief Title
Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms
Official Title
Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Catherine Buettner
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
This study will recruit individuals who have had muscle symptoms while using a statin. During the first part of the study, volunteers will be given a statin medication to see if their muscle symptoms return. Those who experience muscle symptoms on this statin rechallenge will be invited to continue in the second part of the trial, in which participants will be randomly assigned to receive either CoQ10 or a placebo (sugar pill) to take with statin medication. We hypothesize that those who receive CoQ10 will experience an improvement in their muscle symptoms compared to those who receive placebo, and, secondarily, that those who receive CoQ10 will be more likely to continue taking the statin medication.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Weakness, Cramps, Myalgia or Myositis Nos, HMG COA Reductase Inhibitor Adverse Reaction
Keywords
CoQ10, Statins, Myalgia, Muscle Pain, Muscle Weakness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coenzyme Q10
Arm Type
Active Comparator
Arm Description
600 mg of CoQ10 taken as 300 mg (three 100 mg wafers) two times daily. Study wafers: ChewQ (Tishcon Corp, Westbury, NY) are chewable wafers each containing 100 mg of Coenzyme Q10 (ubidecarenone USP). All participants randomized continued use of simvastatin 20 mg started during the run-in phase of the study.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo was manufactured by the manufacturer of ChewQ, Tishcon Corp (Westbury, NY), included the same excipients, but no active CoQ10, and looked and tasted identical to active agent. All participants randomized continued use of simvastatin 20 mg started during the run-in phase of the study.
Intervention Type
Dietary Supplement
Intervention Name(s)
Coenzyme Q10
Intervention Description
300 mg of CoQ10 (three 100 mg chewable tablets) 2 times daily for 4 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo (three chewable tablets) 2 times daily for 4 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use
Description
Clinically significant pain reduction was defined, a priori, as a reduction > 1.5 points on the Brief Pain Inventory-Severity Scale (BPI-SS), range: 0 to 10
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Continuation of Statin
Description
Adherence of statin use was defined a priori as participant using Simvastatin 20 mg /day at the end of 4 weeks and having used >85% of statin doses.
Time Frame
4 weeks
Title
Percentage of Participants With Improvement in Disability Related to Muscle Pain
Description
Disability improvement was based on patient report of improvement they felt was meaningful to them
Time Frame
4 weeks
Title
Percentage of Participants With Adverse Effects
Description
serious adverse effects and possible side effects were tracked through all phases of the study by participant interview and checklist at each visit, up to 4 weeks.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Buettner, MD, MPH
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No consent for sharing IPD from trial participants was obtained when this clinical trial began
Learn more about this trial
Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms
We'll reach out to this number within 24 hrs