A Safety Study Of Pregabalin In Fibromyalgia


Last updated date
Study Location
Pfizer Investigational Site
Little Rock, Arkansas, , United States


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Eligibility Criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Females and Males
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 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 complete the double-blind study.

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

- Patients who experienced a serious adverse event during the previous fibromyalgia
study, which was determined to be related to the study medication.


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Advanced Information
Descriptive Information
Brief Title  ICMJE A Safety Study Of Pregabalin In Fibromyalgia
Official Title  ICMJE A 12-Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia
Brief Summary To evaluate the safety of pregabalin in patients with fibromyalgia.
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: January 26, 2006)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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 complete the double-blind study.

Exclusion Criteria:

  • Patients who experienced a serious adverse event during the previous fibromyalgia study, which was determined to be related to the study medication.
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 NCT00282997
Other Study ID Numbers  ICMJE A0081078
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2007

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