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FibromyalgiaPhase 4NCT01397006

Fibromyalgia of Less Than One Year Duration. Study of Pregabalin

A Phase 4 study testing Pregabalin in people with Fibromyalgia, run by Newton-Wellesley Hospital at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of the study is to evaluate whether pregabalin is effective in treating subjects who have had fibromyalgia for less than one year. Pregabalin has been approved by the FDA for treatment of fibromyalgia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fibromyalgia
What is being tested?
Pregabalin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Sep 2011to Mar 2014
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • Meet the 2010 ACR criteria for diagnosis of fibromyalgia (See Appendix)
  • Meet the 1990 ACR criteria for the classification of fibromyalgia (See Appendix)
  • Patients have a pain VAS > 4
  • Patients are able to understand and sign informed consent
  • Patients are able to understand and complete study questionnaires
  • Patients are prepared to discontinue all pain medications including non-steroidal anti-inflammatory drugs (NSAIDs), and medications for sleep or mood disturbances two weeks prior to beginning the study. Acetaminophen, up to 2 extra-strength, three times daily, will be allowed for break-through pain. Medication use will be surveyed at each visit (See Appendix).
  • Age - > 18
  • Females with no documented evidence of current pregnancy, and willingness to take the necessary precautions to prevent pregnancy for the duration of the study period

Who cannot join

  • • Patients with a significant musculoskeletal or rheumatic disorder that may confuse the diagnosis
  • Any subject with suicidal thoughts in the past or currently
  • Patient with a history of renal disease, heart disease, bleeding problems or low platelet counts
  • Women who are breast feeding
  • Men or women who plan to have children during the course of the study
  • Unable to discontinue any medications prescribed for pain, other than acetaminophen, or any medications for sleep or mood disturbances for at least 2 weeks before the study
Show all 10Show fewer
  • Unable to discontinue any mediations used for sleep disturbances
  • Patients currently being treated for any psychiatric illness including depression or anxiety disorder
  • Patients currently taking antidepressant, anti-anxiety, or antipsychotic medications.
  • Inability to understand and sign informed consent and complete questionnaires.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Newton-Wellesley Hospital

    Newton, Massachusetts, 02462

Other trials in United States

About this study

Official title: Fibromyalgia of Less Than One Year Duration in Primary Care: Treatment Response in a Double Blind, Placebo Controlled Study of Pregabalin

The purpose of the study is to evaluate whether pregabalin is effective in treating subjects who have had fibromyalgia for less than one year. Pregabalin has been approved by the FDA for treatment of fibromyalgia. the purpose of the study is to see if subjects identified through their primary care physicians who have fibromyalgia and have had symptoms for less than one year respond to pregabalin and to identify characteristics of that response.

Read the detailed description

The randomized clinical trial of pregabalin in early-onset fibromyalgia.

At the baseline visit, each subject will be asked if they wish to consider enrolling in Part II. If they agree, the details of the study will be explained and Dr Goldenberg will consent those who wish to enroll in Part II. The first 75 patients who consent will be enrolled in the study, the randomized clinical trial of pregabalin in early-onset fibromyalgia.

After a study subject has been enrolled, they will be randomized to one of two treatment groups. All subjects will be randomized, 1:1 either to the pregabalin group (group A) or the placebo group (group B). Randomization will take place after enrollment via selection of one of a multitude of envelopes containing a random number. Each random number will have been preassigned to either Group A or group B.

Conditions
Fibromyalgia
Being tested
Pregabalin
Keywords
Fibromyalgia, pregabalin, Lyrica
Medical subject headings
Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PregabalinDrug

    Also called Lyrica

    Pregabalin dose escalating every 2 weeks. Starting dose is 75 mg. Titrated up to maximum of 450mg

Study groups in NCT01397006
Study groupRoleWhat they receive
PregabalinExperimentalNot described
Receives: Drug: Pregabalin
PlaceboPlacebo comparatorNot described
Receives: Drug: Pregabalin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pain VAS from study entry to end of study

    Measured: 12 weeks

Secondary outcomes (4)

  1. Change in total score FIQ from study entry to last visit.

    Measured: 12 weeks

  2. Change in total score FM 2010 Clinical Scale from study entry to last visit.

    Measured: 12 Weeks

  3. Change in PGIC from study entry to last visit.

    Measured: 12 weeks

  4. Change in total score for HRQOL from study entry to last visit.

    Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01397006
Sponsor's protocol ID
N11-507
Status last verified
Apr 2014
First submitted
15 Jul 2011
Last updated
14 Apr 2014
Results posted
No
Data monitoring committee
No

Publications

  • Goldenberg DL. Fibromyalgia syndrome a decade later: what have we learned? Arch Intern Med. 1999 Apr 26;159(8):777-85. doi: 10.1001/archinte.159.8.777.

    PubMed 10219923

  • Clauw DJ, Crofford LJ. Chronic widespread pain and fibromyalgia: what we know, and what we need to know. Best Pract Res Clin Rheumatol. 2003 Aug;17(4):685-701. doi: 10.1016/s1521-6942(03)00035-4.

    PubMed 12849719

  • Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.

    PubMed 2306288

  • Goldenberg DL. Introduction: fibromyalgia and its related disorders. J Clin Psychiatry. 2008;69 Suppl 2:4-5. No abstract available.

    PubMed 18537456

  • Goldenberg DL. Pharmacological treatment of fibromyalgia and other chronic musculoskeletal pain. Best Pract Res Clin Rheumatol. 2007 Jun;21(3):499-511. doi: 10.1016/j.berh.2007.02.012.

    PubMed 17602996

  • Goldenberg DL. Fibromyalgia syndrome. An emerging but controversial condition. JAMA. 1987 May 22-29;257(20):2782-7. doi: 10.1001/jama.257.20.2782.

    PubMed 3553636

  • Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

    PubMed 20461783

  • Crofford LJ, Rowbotham MC, Mease PJ, Russell IJ, Dworkin RH, Corbin AE, Young JP Jr, LaMoreaux LK, Martin SA, Sharma U; Pregabalin 1008-105 Study Group. Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2005 Apr;52(4):1264-73. doi: 10.1002/art.20983.

    PubMed 15818684

  • Mease PJ, Russell IJ, Arnold LM, Florian H, Young JP Jr, Martin SA, Sharma U. A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. J Rheumatol. 2008 Mar;35(3):502-14. Epub 2008 Feb 15.

    PubMed 18278830

  • Crofford LJ, Mease PJ, Simpson SL, Young JP Jr, Martin SA, Haig GM, Sharma U. Fibromyalgia relapse evaluation and efficacy for durability of meaningful relief (FREEDOM): a 6-month, double-blind, placebo-controlled trial with pregabalin. Pain. 2008 Jun;136(3):419-431. doi: 10.1016/j.pain.2008.02.027. Epub 2008 Apr 8.

    PubMed 18400400

  • Hauser W, Bernardy K, Uceyler N, Sommer C. Treatment of fibromyalgia syndrome with gabapentin and pregabalin--a meta-analysis of randomized controlled trials. Pain. 2009 Sep;145(1-2):69-81. doi: 10.1016/j.pain.2009.05.014. Epub 2009 Jun 17.

    PubMed 19539427

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pregabalin in people with Fibromyalgia, run by Newton-Wellesley Hospital at 1 site 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?

The sponsor lists 8 inclusion and 10 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 was withdrawn before enrolling participants, so there are no results.

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?

Change in pain VAS from study entry to end of study (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01397006, which also lists 11 linked publications.

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 14 Apr 2014.

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