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D-Ribose for Fatigue in Subjects With Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RiboCor, Inc.
ClinicalTrials.gov Identifier:
NCT01315210
First received: March 10, 2011
Last updated: September 11, 2013
Last verified: September 2013

March 10, 2011
September 11, 2013
May 2011
October 2012   (final data collection date for primary outcome measure)
Subject's Assessment of Fatigue (NRS) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01315210 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fibromyalgia
  • Drug: D-Ribose Powder
    5 g TID for 12 Weeks
  • Dietary Supplement: Placebo Powder
    5 g TID for 12 Weeks
  • Experimental: D-Ribose
    Intervention: Drug: D-Ribose Powder
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo Powder
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
October 2012
October 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01315210
BIOE 02C 010
No
RiboCor, Inc.
RiboCor, Inc.
Not Provided
Principal Investigator: Leslie Crofford, MD University of Kentucky
RiboCor, Inc.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP