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An Open-Label Trial of Pregabalin in Patients With Fibromyalgia

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Viatris

Status and phase

Completed
Phase 3

Conditions

Fibromyalgia

Treatments

Drug: Pregabalin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00151528
A0081057

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 A0081056 and who wish to receive open-label pregabalin therapy.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

93

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Data sourced from clinicaltrials.gov

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