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Pregabalin In Adolescent Patients With Fibromyalgia

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NCT01020526

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Childrens Hospital Los Angeles
Los Angeles, California, 90027 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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
12-18 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 Study
A0081180, and 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 A0081180 which was determined to be related to
the study medication by the investigator or sponsor.

NCT01020526
Pfizer
Completed
Pregabalin In Adolescent Patients With Fibromyalgia

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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
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Fibromyalgia
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
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)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   India,   United States
Taiwan
 
NCT01020526
A0081231
2010-020300-29 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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