An Open-Label Trial of Pregabalin in Patients With Fibromyalgia

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.428 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

428

Conditions

Fibromyalgia

Interventions

PregabalinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (93)

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.

Secondary Outcomes

There are no secondary outcome measures

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

Huntsville, Alabama, United States

Pfizer Investigational Site

Phoenix, Arizona, United States

Pfizer Investigational Site

Phoenix, Arizona, United States

Pfizer Investigational Site

Scottsdale, Arizona, United States

Pfizer Investigational Site

Hot Springs, Arkansas, United States

Pfizer Investigational Site

Little Rock, Arkansas, United States

Pfizer Investigational Site

Beverly Hills, California, United States

Pfizer Investigational Site

Los Alamitos, California, United States

...and 83 more locations