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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain Associated With Fibromyalgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Clinical diagnosis of Fibromyalgia

- Pregabalin naive patient

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Clinical diagnosis of neuropathic pain

NCT01773993
Pfizer
Completed
Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)

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Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)
Special Investigation Of Pregabalin For Fibromyalgia
To collect the efficacy and safety information of Pregabalin on Fibromyalgia patients related to their appropriate use in daily practice.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Primary care clinic and hospital for Fibromyalgia
Pain Associated With Fibromyalgia
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.
Other Name: Lyrica® Capsules 25 mg, Lyrica® Capsules 75 mg, Lyrica® Capsules 150 mg
Pregabalin
Subjects who are treated with pregabalin
Intervention: Drug: Pregabalin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
534
July 31, 2017
July 31, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of Fibromyalgia
  • Pregabalin naive patient

Exclusion Criteria:

  • Clinical diagnosis of neuropathic pain
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01773993
A0081282
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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