An Open-Label Trial of Pregabalin in Patients With Fibromyalgia

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 7, 2005
Last updated: March 7, 2008
Last verified: July 2006

September 7, 2005
March 7, 2008
January 2005
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Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 1 year open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081056.
Same as current
Complete list of historical versions of study NCT00151528 on Archive Site
There are no secondary outcome measures [ Designated as safety issue: No ]
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An Open-Label Trial of Pregabalin in Patients With Fibromyalgia
A Long-Term, 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 A0081056 and who wish to receive open-label pregabalin therapy.
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Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Drug: Pregabalin
Not Provided
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 Identifier (NCT Number) in Medline.
June 2006
Not Provided

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.
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
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Study Director: Pfizer Call Center Pfizer
July 2006

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