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D-Ribose for Fatigue in Subjects With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
D-Ribose Powder
Placebo Powder
Sponsored by
RiboCor, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Fatigue, D-Ribose

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Superior Research, LLC
  • Avail Clinical Research
  • Renstar Medical Research
  • University of Kentucky
  • Columbia Medical Practice
  • The Center for Rheumatology and Bone Research
  • Peters Medical Research
  • Wake Research Associates, LLC
  • Altoona Center for Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

D-Ribose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Subject's Assessment of Fatigue (NRS)

Secondary Outcome Measures

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

Full Information

First Posted
March 10, 2011
Last Updated
September 11, 2013
Sponsor
RiboCor, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01315210
Brief Title
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

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RiboCor, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Fatigue, D-Ribose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
D-Ribose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
D-Ribose Powder
Intervention Description
5 g TID for 12 Weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Powder
Intervention Description
5 g TID for 12 Weeks
Primary Outcome Measure Information:
Title
Subject's Assessment of Fatigue (NRS)
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Revised Fibromyalgia Impact Questionnaire
Time Frame
12 Weeks
Title
Multidimensional Fatigue Inventory
Time Frame
12 Weeks
Title
Subject's Global Impression of Change
Time Frame
12 Weeks
Title
SF-36
Time Frame
12 Weeks
Title
Subject's Assessment of Pain Intensity (NRS)
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Crofford, MD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Superior Research, LLC
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Avail Clinical Research
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Columbia Medical Practice
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
The Center for Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Peters Medical Research
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States

12. IPD Sharing Statement

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D-Ribose for Fatigue in Subjects With Fibromyalgia

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