Adolescent Fibromyalgia Study

This study is currently recruiting participants.
Verified March 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01020474
First received: November 23, 2009
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Drug: placebo
Drug: pregabalin (Lyrica)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Endpoint mean pain score from daily pain diary [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endpoint mean sleep quality score from the daily sleep diary [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Pain Numeric Rating Scale (Pain-NRS) at Termination Visit [ Time Frame: 15weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change at Termination [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Parent Global Impression of Change at Termination Visit [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Fibromyalgia Impact Questionnaire for Children at Termination Visit [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events at every visit. [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
  • Physical and neurological exams. [ Time Frame: week 1 and week 15 (Visit 1 and 10 respectively) ] [ Designated as safety issue: Yes ]
  • Vital signs. [ Time Frame: Visits 1, 2, 6, 8, 9, and 10 ] [ Designated as safety issue: Yes ]
  • Suicidality Tracking Scale (STS). [ Time Frame: Visits 1, 2, 6, 8, 9, and 10 ] [ Designated as safety issue: Yes ]
  • 12-Lead Electrocardiogram (ECG). [ Time Frame: Visit 1 and 10. ] [ Designated as safety issue: Yes ]
  • Laboratory tests: hematology, chemistry, serum pregnancy, urinalysis. [ Time Frame: Visits 1, 6, and 10 ] [ Designated as safety issue: Yes ]
  • Reproductive hormone monitoring (females only) [ Time Frame: Visits 1 and 10 ] [ Designated as safety issue: Yes ]
  • Tanner staging-assessment of pubertal status (females only) [ Time Frame: Visits 1 and 10 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic endpoint: A population pharmacokinetic analysis will be performed using the sparse PK samples obtained at V6. [ Time Frame: week 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 162
Study Start Date: May 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: placebo
matching placebo capsules twice daily.
Experimental: drug-pregabalin Drug: pregabalin (Lyrica)
75-450mg/day pregabalin dose optimised at start of study
Other Name: pregabalin (Lyrica)

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020474

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 28 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01020474     History of Changes
Other Study ID Numbers: A0081180
Study First Received: November 23, 2009
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
juvenile primary fibromyalgia syndrome
pediatric fibromyalgia
pregabalin
and Lyrica

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on April 17, 2014