Adolescent Fibromyalgia Study

Condition(s) targeted: Fibromyalgia

Intervention: placebo (Drug); pregabalin (Lyrica) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

This study will compare pregabalin with placebo over a 15 week period in adolescents with fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.

Official title: A 15 Week, Randomized, Double Blind, Parallel-Group, Placebo-Controlled, Flexible-Dose, Safety And Efficacy Study Of Pregabalin In Adolescents (12-17 Years Old) With Fibromyalgia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Endpoint mean pain score from daily pain diary

Secondary outcome:

Endpoint mean sleep quality score from the daily sleep diary

Pain Numeric Rating Scale (Pain-NRS) at Termination Visit

Patient Global Impression of Change at Termination

Parent Global Impression of Change at Termination Visit

Fibromyalgia Impact Questionnaire for Children at Termination Visit

Frequency and severity of adverse events at every visit.

Physical and neurological exams.

Vital signs.

Suicidality Tracking Scale (STS).

12-Lead Electrocardiogram (ECG).

Laboratory tests: hematology, chemistry, serum pregnancy, urinalysis.

Reproductive hormone monitoring (females only)

Tanner staging-assessment of pubertal status (females only)

Pharmacokinetic endpoint: A population pharmacokinetic analysis will be performed using the sparse PK samples obtained at V6.

Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of fibromyalgia

- 12-17 years of age

Exclusion Criteria:

- Patients with other pain conditions

- Previous treatment with pregabalin

- Patients taking excluded medication

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Ricany 25101, Czech Republic; Recruiting

Pfizer Investigational Site, Changhua 500, Taiwan; Not yet recruiting

Pfizer Investigational Site, Taipei 100, Taiwan; Recruiting

Pfizer Investigational Site, Secunderabad, Andhra Pradesh 500 003, India; Recruiting

Pfizer Investigational Site, Los Angeles, California 90027, United States; Recruiting

Pfizer Investigational Site, Santa Ana, California 92705, United States; Terminated

Pfizer Investigational Site, Coral Gables, Florida 33134, United States; Recruiting

Pfizer Investigational Site, Delray Beach, Florida 33446, United States; Completed

Pfizer Investigational Site, Delray Beach, Florida 33484, United States; Completed

Pfizer Investigational Site, North Miami Beach, Florida 33162, United States; Recruiting

Pfizer Investigational Site, Orlando, Florida 32806, United States; Recruiting

Pfizer Investigational Site, Columbus, Georgia 31909, United States; Recruiting

Pfizer Investigational Site, Lawrenceville, Georgia 30045, United States; Terminated

Pfizer Investigational Site, Maywood, Illinois 60153, United States; Not yet recruiting

Pfizer Investigational Site, Mangalore, Karnataka 575002, India; Recruiting

Pfizer Investigational Site, Louisville, Kentucky 40202, United States; Recruiting

Pfizer Investigational Site, Nagpur, Maharashtra 440010, India; Recruiting

Pfizer Investigational Site, Worcester, Massachusetts 01655, United States; Recruiting

Pfizer Investigational Site, St. Louis, Missouri 63141, United States; Terminated

Pfizer Investigational Site, Durham, North Carolina 27717, United States; Terminated

Pfizer Investigational Site, Raleigh, North Carolina 27609, United States; Terminated

Pfizer Investigational Site, Akron, Ohio 44308, United States; Recruiting

Pfizer Investigational Site, Boardman, Ohio 44512, United States; Recruiting

Pfizer Investigational Site, Cincinnati, Ohio 45219, United States; Recruiting

Pfizer Investigational Site, Columbus, Ohio 43205, United States; Recruiting

Pfizer Investigational Site, Philadelphia, Pennsylvania 19134-1095, United States; Recruiting

Pfizer Investigational Site, Charleston, South Carolina 29425, United States; Recruiting

Pfizer Investigational Site, Myrtle Beach, South Carolina 29572, United States; Terminated

Pfizer Investigational Site, Salt Lake City, Utah 84102, United States; Recruiting

Pfizer Investigational Site, Lucknow, Uttar Pradesh 226 018, India; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: May 2010
Last updated: January 29, 2013