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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00346034
First received: June 28, 2006
Last updated: March 30, 2009
Last verified: March 2009

June 28, 2006
March 30, 2009
December 2006
February 2008   (final data collection date for primary outcome measure)
  • Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score [ Time Frame: Week 12 (end of treatment) ] [ Designated as safety issue: No ]
Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 12 week open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081100.
Complete list of historical versions of study NCT00346034 on ClinicalTrials.gov Archive Site
Not Provided
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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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.
Both
18 Years and older
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
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