Fibromyalgia Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of D-Ribose in Subjects With Fibromyalgia
Verified date | September 2013 |
Source | RiboCor, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To evaluate the safety and to determine the efficacy of D-ribose for the amelioration of fatigue in subjects with fibromyalgia. This is a phase IIa, randomized, double-blind, placebo-controlled, multi-center, multiple dose study of D-ribose versus placebo administered at doses of 5 g three times a day (TID) over a 12-week period to subjects who are experiencing fatigue associated with a diagnosis of fibromyalgia.
Status | Completed |
Enrollment | 110 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Major Inclusion Criteria: - must have a diagnosis of primary fibromyalgia, as defined by the 1990 American College of Rheumatology (ACR) Criteria for the Classification of Fibromyalgia made at least 6 weeks prior to the Pretreatment Screening Visit; - must have a score of =5 on the Subject's Assessment of Fatigue 11-point numerical rating scale (NRS) at the Pretreatment Screening and Baseline Visits; - if taking acetaminophen or other non-opioid analgesics, NSAIDs, fibromyalgia medications, medications to induce sleep, or prednisone = 10 mg (or equivalent dose of other glucocorticoids), must be on stable dose(s) for at least 4 weeks prior to the baseline visit; - must have discontinued any ribose-containing products (including foods, drinks, and supplements) at least 4 weeks prior to the Pretreatment Baseline Visit. Major Exclusion Criteria: - current major depressive episode (MDE); - has been diagnosed with any autoimmune disease; - has been diagnosed with type I or type II diabetes; - has a history of cancer, other than basal cell carcinoma, stage 1 squamous cell carcinoma or cervical carcinoma in situ, that has not been in remission for at least five years prior to the Pretreatment Screening Visit; - has been diagnosed with chronic fatigue syndrome. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Columbia Medical Practice | Columbia | Maryland |
United States | Avail Clinical Research | Deland | Florida |
United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
United States | Peters Medical Research | High Point | North Carolina |
United States | University of Kentucky | Lexington | Kentucky |
United States | Renstar Medical Research | Ocala | Florida |
United States | Wake Research Associates, LLC | Raleigh | North Carolina |
United States | Superior Research, LLC | Sacramento | California |
United States | The Center for Rheumatology and Bone Research | Wheaton | Maryland |
Lead Sponsor | Collaborator |
---|---|
RiboCor, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subject's Assessment of Fatigue (NRS) | 12 Weeks | No | |
Secondary | Revised Fibromyalgia Impact Questionnaire | 12 Weeks | No | |
Secondary | Multidimensional Fatigue Inventory | 12 Weeks | No | |
Secondary | Subject's Global Impression of Change | 12 Weeks | No | |
Secondary | SF-36 | 12 Weeks | No | |
Secondary | Subject's Assessment of Pain Intensity (NRS) | 12 Weeks | No |
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