Trial | NCT01315210  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    d-ribose ...

  • Study Participants

    110
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 Started
May 31
2011
Primary Completion
Oct 31
2012
Study Completion
Oct 31
2012
Last Update
Sep 18
2013
Estimate

Drug D-Ribose Powder

5 g TID for 12 Weeks

Dietary Supplement Placebo Powder

5 g TID for 12 Weeks

D-Ribose Experimental

Placebo Placebo Comparator

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.
No Results Posted