D-Ribose for Fatigue in Subjects With Fibromyalgia

Phase 2

Completed

• Conditions: Fibromyalgia
• Interventions: Drug: D-Ribose Powder; Dietary Supplement: Placebo Powder

• Registration Number: NCT01315210
• Lead Sponsor: RiboCor, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-10
• Study First Submitted QC: 2011-03-13
• Study First Posted: 2011-03-15
• Study Start: 2011-05
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-09
• Disposition First Submitted: 2013-09-11
• Disposition First Submitted QC: 2013-09-11
• Last Update Submitted: 2013-09-11
• Disposition First Posted: 2013-09-18
• Last Update Posted: 2013-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D-Ribose	D-Ribose Powder	-
Placebo	Placebo Powder	-

Primary Outcome Measures

Name	Time	Method
Subject's Assessment of Fatigue (NRS)	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Revised Fibromyalgia Impact Questionnaire	12 Weeks
Multidimensional Fatigue Inventory	12 Weeks
Subject's Assessment of Pain Intensity (NRS)	12 Weeks
Subject's Global Impression of Change	12 Weeks
SF-36	12 Weeks

Trial Locations

Locations (9)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Superior Research, LLC; 🇺🇸 Sacramento, California, United States

Peters Medical Research; 🇺🇸 High Point, North Carolina, United States

Renstar Medical Research; 🇺🇸 Ocala, Florida, United States

Columbia Medical Practice; 🇺🇸 Columbia, Maryland, United States

Wake Research Associates, LLC; 🇺🇸 Raleigh, North Carolina, United States

Altoona Center for Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Avail Clinical Research; 🇺🇸 Deland, Florida, United States

The Center for Rheumatology and Bone Research; 🇺🇸 Wheaton, Maryland, United States