Adolescent Fibromyalgia Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01020474
First received: November 23, 2009
Last updated: August 18, 2014
Last verified: August 2014

November 23, 2009
August 18, 2014
May 2010
April 2015   (final data collection date for primary outcome measure)
change from baseline to week 15 in mean pain diary score [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Endpoint mean pain score from daily pain diary [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01020474 on ClinicalTrials.gov Archive Site
  • change from baseline to week 15 in mean sleep quality diary score [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Pain Numeric Rating Scale (Pain-NRS) [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • weekly change from baseline in mean pain score at weeks 1-15 [ Time Frame: weeks 1-15 ] [ Designated as safety issue: No ]
  • weekly change from baseline in mean sleep quality score at week 1-15 [ Time Frame: weeks 1-15 ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Adolescent Fibromyalgia Study
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fibromyalgia
  • Drug: placebo
    matching placebo capsules twice daily.
  • Drug: pregabalin (Lyrica)
    75-450mg/day pregabalin dose optimised at start of study
    Other Name: pregabalin (Lyrica)
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
  • Experimental: drug-pregabalin
    Intervention: Drug: pregabalin (Lyrica)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
106
April 2015
April 2015   (final data collection date for primary outcome measure)

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
Both
12 Years to 17 Years
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   Czech Republic,   India,   Taiwan
 
NCT01020474
A0081180
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP