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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 11, 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 July 24, 2014