Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)
Information source: Pfizer
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain Associated With Fibromyalgia
Intervention: Pregabalin (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Summary
To collect the efficacy and safety information of Pregabalin on Fibromyalgia patients
related to their appropriate use in daily practice.
Clinical Details
Official title: Special Investigation of Pregabalin (Lyrica) for Fibromyalgia
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Number of Participants with Change from Baseline in Clinical Global Impression of Clinical Condition (CGI-C) at Month X
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical diagnosis of Fibromyalgia
- Pregabalin naive patient
Exclusion Criteria:
- Clinical diagnosis of neuropathic pain
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021 Additional Information
To obtain contact information for a study center near you, click here.
Starting date: January 2013
Last updated: January 18, 2013
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