NCT01315210CompletedPhase 2
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of D-Ribose in Subjects With Fibromyalgia
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- RiboCor, Inc.
- Enrollment
- 110
- Locations
- 9
- Primary Endpoint
- Subject's Assessment of Fatigue (NRS)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Arms & Interventions
D-Ribose
Experimental
Intervention: D-Ribose Powder (Drug)
Placebo
Placebo Comparator
Intervention: Placebo Powder (Dietary Supplement)
Outcomes
Primary Outcomes
Subject's Assessment of Fatigue (NRS)
Time Frame: 12 Weeks
Secondary Outcomes
- Subject's Assessment of Pain Intensity (NRS)(12 Weeks)
- Multidimensional Fatigue Inventory(12 Weeks)
- Revised Fibromyalgia Impact Questionnaire(12 Weeks)
- Subject's Global Impression of Change(12 Weeks)
- SF-36(12 Weeks)
Investigators
Study Sites (9)
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