Pregabalin In Adolescent Patients With Fibromyalgia

NCT ID: NCT01020526

Last Updated: 2021-01-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2015-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pregabalin

Group Type EXPERIMENTAL

pregabalin

Intervention Type DRUG

Oral capsule 75-450 mg/day

Interventions

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pregabalin

Oral capsule 75-450 mg/day

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Childrens Hospital Los Angeles

Los Angeles, California, United States

Site Status

Apex Research Institute

Santa Ana, California, United States

Site Status

Florida Medical Center & Research

Miami, Florida, United States

Site Status

Harmony Clinical Research, Incorporated

North Miami Beach, Florida, United States

Site Status

Rheumatology Associates of Central Florida, PA

Orlando, Florida, United States

Site Status

Medical Research & Health Education Foundation, Inc.

Columbus, Georgia, United States

Site Status

Kosair Charities Pediatric Clinical Research Unit

Louisville, Kentucky, United States

Site Status

Kosair Children's Hospital

Louisville, Kentucky, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

Site Status

University Pediatric Rheumatology of Kentucky, LLC

Louisville, Kentucky, United States

Site Status

University of Massachusetts Memorial Medical Center Department of Pediatrics

Worcester, Massachusetts, United States

Site Status

Akron Children's Hospital

Akron, Ohio, United States

Site Status

Akron Children's Hospital-Mahoning Valley

Boardman, Ohio, United States

Site Status

Akron Children's Hospital

Boardman, Ohio, United States

Site Status

University of Cincinnati Department of Psychiatry and Behavioral Neuroscience

Cincinnati, Ohio, United States

Site Status

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

The Research Institute at Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Medical University of South Carolina, Pediatric Rheumatology

Charleston, South Carolina, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Carolina Research Center

Myrtle Beach, South Carolina, United States

Site Status

Fatigue Consultation Clinic

Salt Lake City, Utah, United States

Site Status

Bioregeneracni a rehabilitacni centrum

Říčany, , Czechia

Site Status

Krishna Institute of Medical Sciences Ltd

Secunderabad, Andhra Pradesh, India

Site Status

Mallikatta Neuro Center

Mangalore, Karnataka, India

Site Status

Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics

Nagpur, Maharashtra, India

Site Status

King George's Medical University

Lucknow, Uttar Pradesh, India

Site Status

Countries

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United States Czechia India

References

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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.

Reference Type DERIVED
PMID: 27475753 (View on PubMed)

Related Links

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Other Identifiers

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2010-020300-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A0081231

Identifier Type: -

Identifier Source: org_study_id

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