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Pregabalin In Adolescent Patients With Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01020526
Recruitment Status : Completed
First Posted : November 25, 2009
Results First Posted : July 1, 2016
Last Update Posted : July 1, 2016
Information provided by (Responsible Party):

November 23, 2009
November 25, 2009
May 24, 2016
July 1, 2016
July 1, 2016
September 2010
June 2015   (Final data collection date for primary outcome measure)
Change From Baseline in Pain Numeric Rating Scale by Week [ Time Frame: Baseline, Weeks 3, 8, 16, 24 and Last Visit. ]
The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement.
Primary Efficacy Endpoint- Pain Numeric Rating Scale (NRS) [ Time Frame: 6 month ]
Complete list of historical versions of study NCT01020526 on Archive Site
Not Provided
There are no secondary endpoints [ Time Frame: There are no secondary endpoints ]
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Pregabalin In Adolescent Patients With Fibromyalgia
A 6-month, Open-label, Safety Trial Of Pregabalin In Adolescent Patients With Fibromyalgia
The main purpose of this study is to evaluate the long-term safety of pregabalin in adolescent patients who participated in the previous fibromyalgia study (A0081180) and who wish to recieve open-label pregabalin
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Phase 4
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: pregabalin
Oral capsule 75-450 mg/day
Experimental: Pregabalin
Intervention: Drug: pregabalin
Arnold LM, Schikler KN, Bateman L, Khan T, Pauer L, Bhadra-Brown P, Clair A, Chew ML, Scavone J; Pregabalin Adolescent Fibromyalgia Study Group. Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study. Pediatr Rheumatol Online J. 2016 Jul 30;14(1):46. doi: 10.1186/s12969-016-0106-4.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2015
June 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and 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 A0081180 which was determined to be related to the study medication by the investigator or sponsor.
Sexes Eligible for Study: All
12 Years to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   India,   United States
2010-020300-29 ( EudraCT Number )
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Study Director: Pfizer Call Center Pfizer
May 2016

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