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Fibromyalgia of Less Than One Year Duration. Study of Pregabalin

Information source: Newton-Wellesley Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fibromyalgia

Intervention: Pregabalin (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: Newton-Wellesley Hospital

Official(s) and/or principal investigator(s):
Don Goldenberg, MD, Principal Investigator, Affiliation: Newton-Wellesley Hospital


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in pain VAS from study entry to end of study

Secondary outcome:

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

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

Change in PGIC from study entry to last visit.

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

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- • 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 Exclusion Criteria:

- • 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

- 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


- Inability to understand and sign informed consent and complete questionnaires.

Locations and Contacts

Newton-Wellesley Hospital, Newton, Massachusetts 02462, United States
Additional Information

Related publications:

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

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. Review.

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.

Goldenberg DL. Introduction: fibromyalgia and its related disorders. J Clin Psychiatry. 2008;69 Suppl 2:4-5.

Goldenberg DL. Pharmacological treatment of fibromyalgia and other chronic musculoskeletal pain. Best Pract Res Clin Rheumatol. 2007 Jun;21(3):499-511. Review.

Starting date: September 2011
Last updated: April 11, 2014

Page last updated: August 23, 2015

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