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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-Ribose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-Ribose Powder | Drug | 5 g TID for 12 Weeks |
| |
| Placebo Powder |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Assessment of Fatigue (NRS) | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Revised Fibromyalgia Impact Questionnaire | 12 Weeks | |
| Multidimensional Fatigue Inventory | 12 Weeks | |
| Subject's Global Impression of Change |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Crofford, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Superior Research, LLC | Sacramento | California | 95825 | United States | ||
| Avail Clinical Research |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Dietary Supplement |
5 g TID for 12 Weeks |
|
| 12 Weeks |
| SF-36 | 12 Weeks |
| Subject's Assessment of Pain Intensity (NRS) | 12 Weeks |
| DeLand |
| Florida |
| 32720 |
| United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Columbia Medical Practice | Columbia | Maryland | 21045 | United States |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | United States |
| Peters Medical Research | High Point | North Carolina | 27262 | United States |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| D009422 |
| Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |