A Controlled Pregabalin Trial In Fibromyalgia

A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00230776

Enrollment

740

Registered

2005-10-03

Start date

2005-10-31

Completion date

2006-07-31

Last updated

2021-01-26

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 efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of patients with fibromyalgia

Interventions

DRUGpregabalin

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

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 have a score of \>40 mm on the Visual Analog Scale

Exclusion criteria

* Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders.

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.	—

Secondary

Measure	Time frame
To evaluate the efficacy of pregabalin for improvement in sleep, fatigue, health-related quality of life, functioning and mood disturbance associated with fibromyalgia. To evaluate safety and tolerability.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026