FibromyalgiaPhase 2NCT01315210
D-Ribose for Fatigue in Subjects With Fibromyalgia
A Phase 2 study testing D-Ribose Powder in people with Fibromyalgia, run by RiboCor, Inc. at 9 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- D-Ribose Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 9 sitesUnited States
- Study dates
- May 2011to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Columbia Medical Practice
Columbia, Maryland, 21045
Avail Clinical Research
DeLand, Florida, 32720
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Peters Medical Research
High Point, North Carolina, 27262
University of Kentucky
Lexington, Kentucky, 40536
Renstar Medical Research
Ocala, Florida, 34471
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Superior Research, LLC
Sacramento, California, 95825
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of D-Ribose in Subjects With Fibromyalgia
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.
- Conditions
- Fibromyalgia
- Being tested
- D-Ribose Powder, Placebo Powder
- Keywords
- Fibromyalgia, Fatigue, D-Ribose
- Medical subject headings
- Fibromyalgia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-Ribose PowderDrug
5 g TID for 12 Weeks
Placebo PowderDietary supplement
5 g TID for 12 Weeks
| Study group | Role | What they receive |
|---|---|---|
| D-Ribose | Experimental | Not described Receives: Drug: D-Ribose Powder |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject's Assessment of Fatigue (NRS)
Measured: 12 Weeks
Secondary outcomes (5)
Revised Fibromyalgia Impact Questionnaire
Measured: 12 Weeks
Multidimensional Fatigue Inventory
Measured: 12 Weeks
Subject's Global Impression of Change
Measured: 12 Weeks
SF-36
Measured: 12 Weeks
Subject's Assessment of Pain Intensity (NRS)
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- RiboCor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leslie Crofford, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315210
- Sponsor's protocol ID
- BIOE 02C 010
- Status last verified
- Sep 2013
- First submitted
- 10 Mar 2011
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of D-Ribose in Subjects With Fibromyalgia
- ClinicalTrials.gov ID
- NCT01315210
- Acronym / sponsor ID
- BIOE 02C 010
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Fatigue, D-Ribose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- RiboCor, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-Ribose | Experimental | Drug: D-Ribose Powder |
| Placebo | Placebo comparator | Dietary Supplement: Placebo Powder |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-Ribose Powder5 g TID for 12 Weeks | Drug | D-Ribose |
| Placebo Powder5 g TID for 12 Weeks | Dietary supplement | Placebo |
Primary outcome
Subject's Assessment of Fatigue (NRS)
Time frame: 12 Weeks
5 secondary outcomes
Revised Fibromyalgia Impact Questionnaire
Time frame: 12 Weeks
Multidimensional Fatigue Inventory
Time frame: 12 Weeks
Subject's Global Impression of Change
Time frame: 12 Weeks
SF-36
Time frame: 12 Weeks
Subject's Assessment of Pain Intensity (NRS)
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Crofford, MD principal investigator
University of Kentucky
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D-Ribose Powder in people with Fibromyalgia, run by RiboCor, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject's Assessment of Fatigue (NRS) (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2013.