This trial is active, not recruiting.

Condition pain associated with fibromyalgia
Treatment pregabalin
Sponsor Pfizer
Start date February 2013
End date June 2017
Trial size 600 participants
Trial identifier NCT01773993, A0081282


To collect the efficacy and safety information of Pregabalin on Fibromyalgia patients related to their appropriate use in daily practice.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Subjects who are treated with pregabalin
pregabalin Lyrica® Capsules 25 mg, Lyrica® Capsules 75 mg, Lyrica® Capsules 150 mg
The usual adult dosage for oral use begins at 150 mg/day of pregabalin twice daily, and should be gradually increased to 300 mg/day over 1 week or more and then maintained at 300-450 mg/day as needed. Dosage should be adjusted, depending on age or symptoms. However, the daily maximum dose should not be beyond 450 mg, and should be orally administered twice daily.

Primary Outcomes

Number of Participants with Change from Baseline in Clinical Global Impression of Clinical Condition (CGI-C) at Month X
time frame: 12 months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Clinical diagnosis of Fibromyalgia - Pregabalin naive patient Exclusion Criteria: - Clinical diagnosis of neuropathic pain

Additional Information

Official title Special Investigation Of Pregabalin For Fibromyalgia
Description All the patients whom an investigator prescribes the first pregabalin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Pfizer.