D-Ribose for Fatigue in Subjects With Fibromyalgia
This study has been completed.
Sponsor:
RiboCor, Inc.
Information provided by (Responsible Party):
RiboCor, Inc.
ClinicalTrials.gov Identifier:
NCT01315210
First received: March 10, 2011
Last updated: January 9, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fibromyalgia |
Drug: D-Ribose Powder Dietary Supplement: Placebo Powder |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of D-Ribose in Subjects With Fibromyalgia |
Resource links provided by NLM:
Further study details as provided by RiboCor, Inc.:
Primary Outcome Measures:
- Subject's Assessment of Fatigue (NRS) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Revised Fibromyalgia Impact Questionnaire [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Multidimensional Fatigue Inventory [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Subject's Global Impression of Change [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- SF-36 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Subject's Assessment of Pain Intensity (NRS) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
| Enrollment: | 110 |
| Study Start Date: | May 2011 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: D-Ribose |
Drug: D-Ribose Powder
5 g TID for 12 Weeks
|
| Placebo Comparator: Placebo |
Dietary Supplement: Placebo Powder
5 g TID for 12 Weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315210
Locations
| United States, California | |
| Superior Research, LLC | |
| Sacramento, California, United States, 95825 | |
| United States, Florida | |
| Avail Clinical Research | |
| Deland, Florida, United States, 32720 | |
| Renstar Medical Research | |
| Ocala, Florida, United States, 34471 | |
| United States, Kentucky | |
| University of Kentucky | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Maryland | |
| Columbia Medical Practice | |
| Columbia, Maryland, United States, 21045 | |
| The Center for Rheumatology and Bone Research | |
| Wheaton, Maryland, United States, 20902 | |
| United States, North Carolina | |
| Peters Medical Research | |
| High Point, North Carolina, United States, 27262 | |
| Wake Research Associates, LLC | |
| Raleigh, North Carolina, United States, 27612 | |
| United States, Pennsylvania | |
| Altoona Center for Clinical Research | |
| Duncansville, Pennsylvania, United States, 16635 | |
Sponsors and Collaborators
RiboCor, Inc.
Investigators
| Principal Investigator: | Leslie Crofford, MD | University of Kentucky |
More Information
No publications provided
| Responsible Party: | RiboCor, Inc. |
| ClinicalTrials.gov Identifier: | NCT01315210 History of Changes |
| Other Study ID Numbers: | BIOE 02C 010 |
| Study First Received: | March 10, 2011 |
| Last Updated: | January 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by RiboCor, Inc.:
|
Fibromyalgia Fatigue D-Ribose |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013