Fibromyalgia of Less Than One Year Duration. Study of Pregabalin

Newton-Wellesley Hospital

Status and phase

Withdrawn

Phase 4

Conditions

Fibromyalgia

Treatments

Drug: Pregabalin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01397006

N11-507

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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