Fibromyalgia of Less Than One Year Duration. Study of Pregabalin
NCT ID: NCT01397006
Last Updated: 2014-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2011-09-30
2014-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pregabalin
Pregabalin
Pregabalin dose escalating every 2 weeks. Starting dose is 75 mg. Titrated up to maximum of 450mg
Placebo
Pregabalin
Pregabalin dose escalating every 2 weeks. Starting dose is 75 mg. Titrated up to maximum of 450mg
Interventions
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Pregabalin
Pregabalin dose escalating every 2 weeks. Starting dose is 75 mg. Titrated up to maximum of 450mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Newton-Wellesley Hospital
OTHER
Responsible Party
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Don L. Goldenberg MD
PI
Principal Investigators
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Don Goldenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Newton-Wellesley Hospital
Locations
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Newton-Wellesley Hospital
Newton, Massachusetts, United States
Countries
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References
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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.
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.
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.
Goldenberg DL. Introduction: fibromyalgia and its related disorders. J Clin Psychiatry. 2008;69 Suppl 2:4-5. No abstract available.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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N11-507
Identifier Type: -
Identifier Source: org_study_id
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