NCT01315210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

September 18, 2013

Status Verified

September 1, 2013

Enrollment Period

1.4 years

First QC Date

March 10, 2011

Last Update Submit

September 11, 2013

Conditions

Fibromyalgia

Keywords

FibromyalgiaFatigueD-Ribose

Outcome Measures

Primary Outcomes (1)

  • Subject's Assessment of Fatigue (NRS)

    12 Weeks

Secondary Outcomes (5)

  • Revised Fibromyalgia Impact Questionnaire

    12 Weeks

  • Multidimensional Fatigue Inventory

    12 Weeks

  • Subject's Global Impression of Change

    12 Weeks

  • SF-36

    12 Weeks

  • Subject's Assessment of Pain Intensity (NRS)

    12 Weeks

Study Arms (2)

D-Ribose

EXPERIMENTAL
Drug: D-Ribose Powder

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo Powder

Interventions

D-Ribose PowderDRUG

5 g TID for 12 Weeks

D-Ribose
Placebo PowderDIETARY_SUPPLEMENT

5 g TID for 12 Weeks

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Superior Research, LLC

Sacramento, California, 95825, United States

Location

Avail Clinical Research

DeLand, Florida, 32720, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Columbia Medical Practice

Columbia, Maryland, 21045, United States

Location

The Center for Rheumatology and Bone Research

Wheaton, Maryland, 20902, United States

Location

Peters Medical Research

High Point, North Carolina, 27262, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

MeSH Terms

Conditions

FibromyalgiaFatigue

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leslie Crofford, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2011

First Posted

March 15, 2011

Study Start

May 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

September 18, 2013

Record last verified: 2013-09

Locations

US(9)