A Safety Study Of Pregabalin In Fibromyalgia

A 12-Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00282997

Enrollment

500

Registered

2006-01-27

Start date

2006-02-28

Completion date

2006-10-31

Last updated

2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Brief summary

To evaluate the safety of pregabalin in patients with fibromyalgia.

Interventions

DRUGpregabalin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites. * Patients must complete the double-blind study.

Exclusion criteria

* Patients who experienced a serious adverse event during the previous fibromyalgia study, which was determined to be related to the study medication.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety of pregabalin in patients with fibromyalgia	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026