This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia

Viatris

Status and phase: Completed; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00346034

A0081101

Details and patient eligibility

About

The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081100 and who wish to receive open-label pregabalin therapy.

Enrollment: 357 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081100, and 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 A0081100 which was determined to be related to the study medication by the investigator or the sponsor.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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357 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Pregabalin