Adolescent Fibromyalgia Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01020474
First received: November 23, 2009
Last updated: June 22, 2015
Last verified: June 2015

November 23, 2009
June 22, 2015
May 2010
December 2014   (final data collection date for primary outcome measure)
Change From Baseline to Week 15 in Mean Pain Diary Score [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
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").
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: Week 15 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).
  • 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
  • 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.
 
Completed
107
December 2014
December 2014   (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   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   India,   Taiwan
 
NCT01020474
A0081180, 2010-019521-34
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2015

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