An Open-Label Trial of Pregabalin in Patients With Fibromyalgia

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NCT00151528

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294-3405, United States
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Contact
1-800-718-1021
ClinicalTrials.go[email protected]
Related Links

FOR MORE INFORMATION

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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 A0081056

- 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 A0081056 which was determined to be related to
the study medication by the investigator or the sponsor.

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FibromyalgiaAn Open-Label Trial of Pregabalin in Patients With Fibromyalgia
NCT00151528
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Huntsville, Alabama
  4. Phoenix, Arizona
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  7. Hot Springs, Arkansas
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  94. Yakima, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE An Open-Label Trial of Pregabalin in Patients With Fibromyalgia
Official Title  ICMJE A Long-Term, Open-Label, Safety Trial of Pregabalin in Patients With Fibromyalgia
Brief Summary The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081056 and who wish to receive open-label pregabalin therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE Drug: Pregabalin
Study Arms  ICMJE Not Provided
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 8, 2005)		428
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081056
  • 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 A0081056 which was determined to be related to the study medication by the investigator or the sponsor.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00151528
Other Study ID Numbers  ICMJE A0081057
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP