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A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Genova Clinical Research
Tucson, Arizona, 85704 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fibromyalgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Men or women of any race or ethnicity who are at least 18 years of age.

- Adult women and men with a diagnosis of fibromyalgia and stable depression (major
depressive disorder, depression not otherwise specified (NOS), or dysthymia) who have
been taking an antidepressant (SSRI or SNRI) primarily for their depression for at
least 3 months.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Have failed pregabalin treatment due to lack of improvement of symptoms at doses of
greater than or equal to 300 mg daily, cannot tolerate pregabalin or any pregabalin
ingredient, or participated in a pregabalin clinical trial. If the subject has taken
pregabalin and discontinued for reason other than lack of improvement or intolerance,
then they will be eligible. Pregabalin use within the last 30 days (prior to V1) is
not permitted.

- Patients with severe or unstable depression are not eligible.

- Patients with other types of pain or conditions that may make it difficult to evaluate
fibromyalgia symptoms are not eligible

- Any subject considered at risk of suicide or self harm based on investigator judgment
and/or the details of a risk assessment

NCT01432236
Pfizer
Completed
A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now