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Adolescent Fibromyalgia Study

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ClinicalTrials.gov Identifier: NCT01020474
Recruitment Status : Completed
First Posted : November 25, 2009
Results First Posted : June 25, 2015
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 23, 2009
First Posted Date  ICMJE November 25, 2009
Results First Submitted Date  ICMJE May 26, 2015
Results First Posted Date  ICMJE June 25, 2015
Last Update Posted Date June 25, 2015
Study Start Date  ICMJE May 2010
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2015)
Change From Baseline to Week 15 in Mean Pain Diary Score [ Time Frame: Week 15 ]
The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 ("no pain") and 10 ("worst possible pain").
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2009)
Endpoint mean pain score from daily pain diary [ Time Frame: 15 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2015)
  • Change From Baseline to Week 15 in Mean Sleep Quality Diary Score [ Time Frame: Week 15 ]
    Change from Baseline to endpoint in mean sleep quality score from the daily sleep diary, defined as the mean of the last 7 diary entries prior to Visit 10 in the study while the participant is on study medication. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates "best possible sleep" and 10 indicates "worst possible sleep".
  • Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) [ Time Frame: Baseline to Week 15 ]
    Mean pain score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). For each week, only days up to the last day on study medication were considered. A minimum of 4 pain diaries were required to calculate the mean pain score. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).
  • Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) [ Time Frame: Baseline to Week 15 ]
    Mean sleep quality score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). A minimum of 4 sleep diaries are required to calculate the mean pain score. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates "best possible sleep" and 10 indicates "worst possible sleep".
  • Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period) [ Time Frame: Week 15 ]
    The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater degree of impairment. Participants choose the number that best describes the pain during the last week.
  • Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15 [ Time Frame: Week 15 ]
    At each visit, participants with at least 30% reduction from Baseline in mean pain score were defined as a 30% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).
  • Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15 [ Time Frame: Week 15 ]
    At each visit, participants with at least 50% reduction from Baseline in mean pain score were defined as a 50% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).
  • Proportion of Patient Global Impression Change (PGIC) at Week 15 [ Time Frame: Week 15 ]
    Responder rates based on PGIC was derived and tabulated by treatment group. A responder was defined as a participant who reports much improved or very much improved. The PGIC is a patient-rated single item that measures patient's perception of change in their overall status since starting study medication on a scale ranging from 1 (very much improved) to 7 (very much worse).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2009)
  • Endpoint mean sleep quality score from the daily sleep diary [ Time Frame: 15 weeks ]
  • Pain Numeric Rating Scale (Pain-NRS) at Termination Visit [ Time Frame: 15weeks ]
  • Patient Global Impression of Change at Termination [ Time Frame: 15 weeks ]
  • Parent Global Impression of Change at Termination Visit [ Time Frame: 15 weeks ]
  • Fibromyalgia Impact Questionnaire for Children at Termination Visit [ Time Frame: 15 weeks ]
  • Frequency and severity of adverse events at every visit. [ Time Frame: 15 weeks ]
  • Physical and neurological exams. [ Time Frame: week 1 and week 15 (Visit 1 and 10 respectively) ]
  • Vital signs. [ Time Frame: Visits 1, 2, 6, 8, 9, and 10 ]
  • Suicidality Tracking Scale (STS). [ Time Frame: Visits 1, 2, 6, 8, 9, and 10 ]
  • 12-Lead Electrocardiogram (ECG). [ Time Frame: Visit 1 and 10. ]
  • Laboratory tests: hematology, chemistry, serum pregnancy, urinalysis. [ Time Frame: Visits 1, 6, and 10 ]
  • Reproductive hormone monitoring (females only) [ Time Frame: Visits 1 and 10 ]
  • Tanner staging-assessment of pubertal status (females only) [ Time Frame: Visits 1 and 10 ]
  • Pharmacokinetic endpoint: A population pharmacokinetic analysis will be performed using the sparse PK samples obtained at V6. [ Time Frame: week 3 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adolescent Fibromyalgia Study
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Drug: placebo
    matching placebo capsules twice daily.
  • Drug: pregabalin (Lyrica)
    75-450mg/day pregabalin dose optimised at start of study
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
  • Experimental: drug-pregabalin
    Intervention: Drug: pregabalin (Lyrica)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2015)
107
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2009)
162
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   India,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01020474
Other Study ID Numbers  ICMJE A0081180
2010-019521-34 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2015

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