NCT01773993

Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)

SPECIAL INVESTIGATION OF PREGABALIN FOR FIBROMYALGIA

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 534 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 0 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Pain Associated With Fibromyalgia

Interventions

Type	Name	Description
DRUG	Pregabalin	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.

Timeline

• Start date: 2013-02-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2013-01-23
• Last updated: 2023-10-10
• Results posted: 2019-05-03