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An fMRI Study Of Brain Response In Patients With Fibromyalgia

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NCT00760474

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Ann Arbor, Michigan, 48106 United States
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fibromyalgia
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Women must have pain due to fibromyalgia

- Fibromyalgia must have been diagnosed at least 6 months prior to be eligible for this
study

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

- Patients with severe depression or other serious illness, who are left-handed, or who
are pregnant or nursing are not eligible for this study.

NCT00760474
Pfizer
Completed
An fMRI Study Of Brain Response In Patients With Fibromyalgia

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[email protected]

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An fMRI Study Of Brain Response In Patients With Fibromyalgia
A Double-Blind, Placebo-Controlled Cross-Over Study In Fibromyalgia Subjects To Examine Effects Of Pregabalin On Brain Response To Mechanical Pain As Assessed By Functional Magnetic Resonance Imaging, Proton Magnetic Resonance Spectroscopy And Subjective Ratings
The purpose of this study is to explore how pregabalin works in patients with fibromyalgia by evaluating brain imaging signals. To find out whether fMRI (functional magnetic resonance imaging) is an efficient way to show whether new pain medications are effective in treating fibromyalgia.
Methodology study
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Fibromyalgia
  • Drug: Pregabalin, then placebo
    Placebo and pregabalin will be given orally twice daily in capsules at different times during the course of the study. The highest dose of pregabalin to be used in the study is 450 mg/day.
  • Drug: Placebo, then pregabalin
    Placebo and pregabalin will be given orally twice daily in capsules at different times during the course of the study. The highest dose of pregabalin to be used in the study is 450 mg/day.
  • Experimental: Pregabalin, then placebo
    Intervention: Drug: Pregabalin, then placebo
  • Experimental: Placebo, then pregabalin
    Intervention: Drug: Placebo, then pregabalin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
March 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women must have pain due to fibromyalgia
  • Fibromyalgia must have been diagnosed at least 6 months prior to be eligible for this study

Exclusion Criteria:

  • Patients with severe depression or other serious illness, who are left-handed, or who are pregnant or nursing are not eligible for this study.
Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00760474
A0081211
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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