D-Ribose for Fatigue in Subjects With Fibromyalgia



Status:Completed
Conditions:Fibromyalgia, Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:May 2011
End Date:July 2012

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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of D-Ribose in Subjects With Fibromyalgia


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.


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.
We found this trial at
9
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175 Meadowbrook Lane
, Pennsylvania 16635
814-693-0300
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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Columbia, Maryland 21045
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HIgh Point, North Carolina 27262
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Lexington, Kentucky
859) 257-9000
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Sacramento, California 95825
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Wheaton, MD
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