Clinical trial NCT01020526: Pregabalin In Adolescent Patients With Fibromyalgia
Official title: A 6-month, Open-label, Safety Trial Of Pregabalin In Adolescent Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fibromyalgia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 63
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Pain Numeric Rating Scale by Week
timeFrame: Baseline, Weeks 3, 8, 16, 24 and Last Visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital Los Angeles
state: California
city: Santa Ana
country: United States
facility: Apex Research Institute
state: California
city: Miami
country: United States
facility: Florida Medical Center & Research
state: Florida
city: North Miami Beach
country: United States
facility: Harmony Clinical Research, Incorporated
state: Florida
city: Orlando
country: United States
facility: Rheumatology Associates of Central Florida, PA
state: Florida
city: Columbus
country: United States
facility: Medical Research & Health Education Foundation, Inc.
state: Georgia
city: Louisville
country: United States
facility: Kosair Charities Pediatric Clinical Research Unit
state: Kentucky
city: Louisville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Louisville
country: United States
facility: University Pediatric Rheumatology of Kentucky, LLC
state: Kentucky
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center Department of Pediatrics
state: Massachusetts
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Boardman
country: United States
facility: Akron Children's Hospital-Mahoning Valley
state: Ohio
city: Boardman
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Department of Psychiatry and Behavioral Neuroscience
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: The Research Institute at Nationwide Children's Hospital
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina, Pediatric Rheumatology
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Research Center
state: South Carolina
city: Salt Lake City
country: United States
facility: Fatigue Consultation Clinic
state: Utah
city: Ricany
country: Czechia
facility: Bioregeneracni a rehabilitacni centrum
city: Secunderabad
country: India
facility: Krishna Institute of Medical Sciences Ltd
state: Andhra Pradesh
city: Mangalore
country: India
facility: Mallikatta Neuro Center
state: Karnataka
city: Nagpur
country: India
facility: Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
state: Maharashtra
city: Lucknow
country: India
facility: King George's Medical University
state: Uttar Pradesh
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.