Status:
COMPLETED
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Fibromyalgia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will assess the safety and efficacy of the long-term use of pregabalin at doses up to 450 mg/day in patients with fibromyalgia who have completed 16 weeks of dosing in Study A0081208 (NCT00...
Eligibility Criteria
Inclusion
- Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081208, and must have received pregabalin/placebo under double-blind conditions.
Exclusion
- Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081208; which was determined to be related to the study medication by the investigator or the sponsor.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00830128
Start Date
July 1 2009
End Date
February 1 2011
Last Update
January 25 2021
Active Locations (19)
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1
Pfizer Investigational Site
Yotukaidou, Chiba, Japan
2
Pfizer Investigational Site
Matuyama-si, Ehime, Japan
3
Pfizer Investigational Site
Iiduka, Fukuoka, Japan
4
Pfizer Investigational Site
Kobe, Hyōgo, Japan