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This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia

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NCT00346034

Last updated on March 25, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Kelowna, British Columbia, V1Y 2H4 Canada
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.
Show details

- Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol
A0081100, and must have received pregabalin/placebo under double-blind conditions.

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

- Patients may not participate in the study if they experienced a serious adverse event
during the previous fibromyalgia Study A0081100 which was determined to be related to
the study medication by the investigator or the sponsor.

NCT00346034
Pfizer
Completed
This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia

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Pfizer Clinical Trials Contact Center

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[email protected]

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This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia
A 12 Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia
The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081100 and who wish to receive open-label pregabalin therapy.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Fibromyalgia
Drug: Pregabalin
150 to 600mg/day
Experimental: 1
Intervention: Drug: Pregabalin
Arnold LM, Emir B, Murphy TK, Zeiher BG, Pauer L, Scott G, Petersel D. Safety profile and tolerability of up to 1 year of pregabalin treatment in 3 open-label extension studies in patients with fibromyalgia. Clin Ther. 2012 May;34(5):1092-102. doi: 10.1016/j.clinthera.2012.03.003. Epub 2012 Apr 14.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
357
February 2008
February 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081100, and 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 A0081100 which was determined to be related to the study medication by the investigator or the sponsor.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Denmark,   France,   Germany,   India,   Italy,   Korea, Republic of,   Netherlands,   Portugal,   Sweden,   Switzerland,   United Kingdom
 
 
NCT00346034
A0081101
No
Not Provided
Not Provided
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2009

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.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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