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Pregabalin In Adolescent Patients With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
pregabalin
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

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and have received pregabalin/placebo under double-blind conditions.

Exclusion Criteria:

  • Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia study A0081180 which was determined to be related to the study medication by the investigator or sponsor.

Sites / Locations

  • Childrens Hospital Los Angeles
  • Apex Research Institute
  • Florida Medical Center & Research
  • Harmony Clinical Research, Incorporated
  • Rheumatology Associates of Central Florida, PA
  • Medical Research & Health Education Foundation, Inc.
  • 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
  • Akron Children's Hospital
  • Akron Children's Hospital-Mahoning Valley
  • Akron Children's Hospital
  • University of Cincinnati Department of Psychiatry and Behavioral Neuroscience
  • Nationwide Children's Hospital
  • The Research Institute at Nationwide Children's Hospital
  • Medical University of South Carolina, Pediatric Rheumatology
  • Medical University of South Carolina
  • Carolina Research Center
  • Fatigue Consultation Clinic
  • Bioregeneracni a rehabilitacni centrum
  • Krishna Institute of Medical Sciences Ltd
  • Mallikatta Neuro Center
  • Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
  • King George's Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pregabalin

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Pain Numeric Rating Scale by Week
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 worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement.

Secondary Outcome Measures

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
NCT01020526
Brief Title
Pregabalin In Adolescent Patients With Fibromyalgia
Official Title
A 6-month, Open-label, Safety Trial Of Pregabalin In Adolescent Patients With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (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
The main purpose of this study is to evaluate the long-term safety of pregabalin in adolescent patients who participated in the previous fibromyalgia study (A0081180) and who wish to recieve open-label pregabalin

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
Oral capsule 75-450 mg/day
Primary Outcome Measure Information:
Title
Change From Baseline in Pain Numeric Rating Scale by Week
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 worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement.
Time Frame
Baseline, Weeks 3, 8, 16, 24 and Last Visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and have received pregabalin/placebo under double-blind conditions. Exclusion Criteria: Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia study A0081180 which was determined to be related to the study medication by the investigator or sponsor.
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
Florida Medical Center & Research
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
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
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Akron Children's Hospital-Mahoning Valley
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Facility Name
Akron Children's Hospital
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Facility Name
University of Cincinnati Department of Psychiatry and Behavioral Neuroscience
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
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
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 Center
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
King George's Medical University
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226 018
Country
India

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=A0081231&StudyName=Pregabalin%20In%20Adolescent%20Patients%20With%20Fibromyalgia
Description
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Pregabalin In Adolescent Patients With Fibromyalgia

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