Clinical trial NCT01315210: D-Ribose for Fatigue in Subjects With Fibromyalgia
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of D-Ribose in Subjects With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Fatigue
D-Ribose
Lead sponsor: RiboCor, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-15
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Subject's Assessment of Fatigue (NRS)
timeFrame: 12 Weeks
Secondary outcomes:
measure: Revised Fibromyalgia Impact Questionnaire
timeFrame: 12 Weeks
measure: Multidimensional Fatigue Inventory
timeFrame: 12 Weeks
measure: Subject's Global Impression of Change
timeFrame: 12 Weeks
measure: SF-36
timeFrame: 12 Weeks
measure: Subject's Assessment of Pain Intensity (NRS)
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Superior Research, LLC
state: California
city: Deland
country: United States
facility: Avail Clinical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Columbia
country: United States
facility: Columbia Medical Practice
state: Maryland
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
Study officials:
affiliation: University of Kentucky
name: Leslie Crofford, MD
role: PRINCIPAL_INVESTIGATOR
References: