A Long-Term, Open-Label, Safety Trial of Pregabalin in Patients With Fibromyalgia

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country428 target enrollmentJanuary 2005

ConditionsFibromyalgia

DrugsPregabalin

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Fibromyalgia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 428
Locations: 1
Primary Endpoint: Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 1 year open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081056.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081056 and who wish to receive open-label pregabalin therapy.

Registry

clinicaltrials.gov

Start Date

January 2005

End Date

June 2006

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081056
•Must have received pregabalin/placebo under double-blind conditions.

Exclusion Criteria

•Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081056 which was determined to be related to the study medication by the investigator or the sponsor.

Outcomes

Primary Outcomes

Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 1 year open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081056.