NCT01397006

Fibromyalgia of Less Than One Year Duration. Study of Pregabalin

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Newton-Wellesley Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

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

Interventions

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

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2011-07-19
• Last updated: 2014-04-14

Locations

1 site across 1 country: United States