search
Back to results

A Safety Study Of Pregabalin In Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
pregabalin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites. Patients must complete the double-blind study. Exclusion Criteria: Patients who experienced a serious adverse event during the previous fibromyalgia study, which was determined to be related to the study medication.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

To evaluate the safety of pregabalin in patients with fibromyalgia

Secondary Outcome Measures

Full Information

First Posted
January 26, 2006
Last Updated
January 21, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00282997
Brief Title
A Safety Study Of Pregabalin In Fibromyalgia
Official Title
A 12-Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (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

5. Study Description

Brief Summary
To evaluate the safety of pregabalin in patients with fibromyalgia.

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 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pregabalin
Primary Outcome Measure Information:
Title
To evaluate the safety of pregabalin in patients with fibromyalgia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites. Patients must complete the double-blind study. Exclusion Criteria: Patients who experienced a serious adverse event during the previous fibromyalgia study, which was determined to be related to the study 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
Pfizer Investigational Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Pfizer Investigational Site
City
Fresno
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
La Jolla
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Northridge
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Pismo Beach
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Sacramento
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Newark
State/Province
Delaware
Country
United States
Facility Name
Pfizer Investigational Site
City
DeLand
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Melbourne
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Ocala
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Palm Harbor
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Sunrise
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Gurnee
State/Province
Illinois
Country
United States
Facility Name
Pfizer Investigational Site
City
Moline
State/Province
Illinois
Country
United States
Facility Name
Pfizer Investigational Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Pfizer Investigational Site
City
Dubuque
State/Province
Iowa
Country
United States
Facility Name
Pfizer Investigational Site
City
Prairie Village
State/Province
Kansas
Country
United States
Facility Name
Pfizer Investigational Site
City
Pratt
State/Province
Kansas
Country
United States
Facility Name
Pfizer Investigational Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Pfizer Investigational Site
City
Kenner
State/Province
Louisiana
Country
United States
Facility Name
Pfizer Investigational Site
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
Pfizer Investigational Site
City
North Dartmouth
State/Province
Massachusetts
Country
United States
Facility Name
Pfizer Investigational Site
City
Watertown
State/Province
Massachusetts
Country
United States
Facility Name
Pfizer Investigational Site
City
Worcester
State/Province
Massachusetts
Country
United States
Facility Name
Pfizer Investigational Site
City
Chaska
State/Province
Minnesota
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Paul
State/Province
Minnesota
Country
United States
Facility Name
Pfizer Investigational Site
City
Jefferson City
State/Province
Missouri
Country
United States
Facility Name
Pfizer Investigational Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Pfizer Investigational Site
City
Lincoln
State/Province
Nebraska
Country
United States
Facility Name
Pfizer Investigational Site
City
Morristown
State/Province
New Jersey
Country
United States
Facility Name
Pfizer Investigational Site
City
Albany
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Endwell
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
West Seneca
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Hickory
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Salisbury
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Minot
State/Province
North Dakota
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Pfizer Investigational Site
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Pfizer Investigational Site
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Pfizer Investigational Site
City
Bethlehem
State/Province
Pennsylvania
Country
United States
Facility Name
Pfizer Investigational Site
City
Norristown
State/Province
Pennsylvania
Country
United States
Facility Name
Pfizer Investigational Site
City
Goose Creek
State/Province
South Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Mount Pleasant
State/Province
South Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Myrtle Beach
State/Province
South Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Summerville
State/Province
South Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Pfizer Investigational Site
City
Milan
State/Province
Tennessee
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Pfizer Investigational Site
City
Bedford
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Georgetown
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Killeen
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Lake Jackson
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Pfizer Investigational Site
City
Woodstock
State/Province
Vermont
Country
United States
Facility Name
Pfizer Investigational Site
City
Virginia Beach
State/Province
Virginia
Country
United States
Facility Name
Pfizer Investigational Site
City
Everett
State/Province
Washington
Country
United States
Facility Name
Pfizer Investigational Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Pfizer Investigational Site
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
Pfizer Investigational Site
City
Milwaukee
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22503162
Citation
Arnold LM, Emir B, Murphy TK, Zeiher BG, Pauer L, Scott G, Petersel D. Safety profile and tolerability of up to 1 year of pregabalin treatment in 3 open-label extension studies in patients with fibromyalgia. Clin Ther. 2012 May;34(5):1092-102. doi: 10.1016/j.clinthera.2012.03.003. Epub 2012 Apr 14.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081078&StudyName=A+Safety+Study+Of+Pregabalin+In+Fibromyalgia
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Safety Study Of Pregabalin In Fibromyalgia

We'll reach out to this number within 24 hrs