D-Ribose for Fatigue in Subjects With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01315210
• Other study ID #: BIOE 02C 010
• Status: Completed
• Phase: Phase 2
• First received: March 10, 2011
• Last updated: September 11, 2013
• Start date: May 2011
• Est. completion date: October 2012

Study information

• Verified date: September 2013
• Source: RiboCor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• D-Ribose Powder
5 g TID for 12 Weeks

Dietary Supplement:
• Placebo Powder
5 g TID for 12 Weeks

Locations

Country	Name	City	State
United States	Columbia Medical Practice	Columbia	Maryland
United States	Avail Clinical Research	Deland	Florida
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Peters Medical Research	High Point	North Carolina
United States	University of Kentucky	Lexington	Kentucky
United States	Renstar Medical Research	Ocala	Florida
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Superior Research, LLC	Sacramento	California
United States	The Center for Rheumatology and Bone Research	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
RiboCor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject's Assessment of Fatigue (NRS)		12 Weeks	No
Secondary	Revised Fibromyalgia Impact Questionnaire		12 Weeks	No
Secondary	Multidimensional Fatigue Inventory		12 Weeks	No
Secondary	Subject's Global Impression of Change		12 Weeks	No
Secondary	SF-36		12 Weeks	No
Secondary	Subject's Assessment of Pain Intensity (NRS)		12 Weeks	No