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Adolescent Fibromyalgia Study

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
placebo
pregabalin (Lyrica)
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring juvenile primary fibromyalgia syndrome, pediatric fibromyalgia, pregabalin, and Lyrica

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Childrens Hospital Los Angeles
  • Apex Research Institute
  • Eileen Messing, Psy D.
  • Arthritis Associates of South Florida
  • Delray Research Associates
  • Florida Medical Center and Research, Inc.
  • Harmony Clinical Research, Incorporated
  • Rheumatology Associates of Central Florida, PA
  • Medical Research & Health Education Foundation, Inc.
  • North Georgia Rheumatology, PC
  • Kosair Charities Pediatric Clinical Research Unit
  • Kosair Children's Hospital
  • University of Louisville
  • University Pediatric Rheumatology of Kentucky, LLC
  • University of Massachusetts Memorial Medical Center Department of Pediatrics
  • A&A Pain Institute of St. Louis
  • Duke University Medical Center
  • Duke Medicine Plaza
  • Akron Children's Hospital
  • Akron Children's Hospital
  • Boardman Medical Pavilion
  • University of Cincinnati
  • Nationwide Children's Hospital
  • The Research Institute at Nationwide Children's Hospital
  • St. Christopher's Hospital for Children / Section of Rheumatology
  • Medical University of South Carolina, Pediatric Rheumatology
  • Medical University of South Carolina
  • MUSC University Children's Hospital
  • Carolina Research Center
  • Fatigue Consultation Clinic
  • Bioregeneracni a rehabilitacni centrum
  • Krishna Institute of Medical Sciences Ltd
  • Mallikatta Neuro Centre
  • Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
  • Department of Physical Medicine & Rehabilitation
  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

drug-pregabalin

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline to Week 15 in Mean Pain Diary Score
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").

Secondary Outcome Measures

Change From Baseline to Week 15 in Mean Sleep Quality Diary Score
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)
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)
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)
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
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
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
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).

Full Information

First Posted
November 23, 2009
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01020474
Brief Title
Adolescent Fibromyalgia Study
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 Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
juvenile primary fibromyalgia syndrome, pediatric fibromyalgia, pregabalin, and Lyrica

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
drug-pregabalin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
matching placebo capsules twice daily.
Intervention Type
Drug
Intervention Name(s)
pregabalin (Lyrica)
Intervention Description
75-450mg/day pregabalin dose optimised at start of study
Primary Outcome Measure Information:
Title
Change From Baseline to Week 15 in Mean Pain Diary Score
Description
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").
Time Frame
Week 15
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 15 in Mean Sleep Quality Diary Score
Description
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".
Time Frame
Week 15
Title
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Description
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).
Time Frame
Baseline to Week 15
Title
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Description
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".
Time Frame
Baseline to Week 15
Title
Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)
Description
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.
Time Frame
Week 15
Title
Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15
Description
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).
Time Frame
Week 15
Title
Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15
Description
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).
Time Frame
Week 15
Title
Proportion of Patient Global Impression Change (PGIC) at Week 15
Description
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).
Time Frame
Week 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Childrens Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Apex Research Institute
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Eileen Messing, Psy D.
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33446
Country
United States
Facility Name
Arthritis Associates of South Florida
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Delray Research Associates
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Florida Medical Center and Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Harmony Clinical Research, Incorporated
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Rheumatology Associates of Central Florida, PA
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Medical Research & Health Education Foundation, Inc.
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
North Georgia Rheumatology, PC
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
Kosair Charities Pediatric Clinical Research Unit
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University Pediatric Rheumatology of Kentucky, LLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center Department of Pediatrics
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
A&A Pain Institute of St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27717
Country
United States
Facility Name
Duke Medicine Plaza
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Akron Children's Hospital
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Facility Name
Boardman Medical Pavilion
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
The Research Institute at Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
St. Christopher's Hospital for Children / Section of Rheumatology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134-1095
Country
United States
Facility Name
Medical University of South Carolina, Pediatric Rheumatology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
MUSC University Children's Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Carolina Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Fatigue Consultation Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Bioregeneracni a rehabilitacni centrum
City
Ricany
ZIP/Postal Code
25101
Country
Czechia
Facility Name
Krishna Institute of Medical Sciences Ltd
City
Secunderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 003
Country
India
Facility Name
Mallikatta Neuro Centre
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575002
Country
India
Facility Name
Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440010
Country
India
Facility Name
Department of Physical Medicine & Rehabilitation
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226 018
Country
India
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
27475753
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081180&StudyName=Adolescent%20Fibromyalgia%20Study
Description
To obtain contact information for a study center near you, click here.

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Adolescent Fibromyalgia Study

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