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An Open-Label Trial of Pregabalin in Patients With 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 have met the inclusion criteria for the preceding fibromyalgia Protocol A0081056 Must 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 A0081056 which was determined to be related to the study medication by the investigator or the sponsor.

Sites / Locations

  • Pfizer Investigational Site
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Outcomes

Primary Outcome Measures

Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 1 year open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081056.

Secondary Outcome Measures

There are no secondary outcome measures

Full Information

First Posted
September 7, 2005
Last Updated
January 20, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00151528
Brief Title
An Open-Label Trial of Pregabalin in Patients With Fibromyalgia
Official Title
A Long-Term, Open-Label, Safety Trial of Pregabalin in Patients With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)

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
The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081056 and who wish to receive open-label pregabalin therapy.

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
428 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pregabalin
Primary Outcome Measure Information:
Title
Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 1 year open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081056.
Secondary Outcome Measure Information:
Title
There are no secondary outcome measures

10. Eligibility

Sex
All
Minimum 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 Protocol A0081056 Must 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 A0081056 which was determined to be related to the study medication by the investigator or the 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
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3405
Country
United States
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-6909
Country
United States
Facility Name
Pfizer Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Pfizer Investigational Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Pfizer Investigational Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Pfizer Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205-7101
Country
United States
Facility Name
Pfizer Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pfizer Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Pfizer Investigational Site
City
Northridge
State/Province
California
ZIP/Postal Code
91324-4625
Country
United States
Facility Name
Pfizer Investigational Site
City
Pismo Beach
State/Province
California
ZIP/Postal Code
93449
Country
United States
Facility Name
Pfizer Investigational Site
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Pfizer Investigational Site
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Pfizer Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Pfizer Investigational Site
City
Whittier
State/Province
California
ZIP/Postal Code
90601
Country
United States
Facility Name
Pfizer Investigational Site
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Pfizer Investigational Site
City
New Milford
State/Province
Connecticut
ZIP/Postal Code
06776
Country
United States
Facility Name
Pfizer Investigational Site
City
Stratford
State/Province
Connecticut
ZIP/Postal Code
06615
Country
United States
Facility Name
Pfizer Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Pfizer Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Pfizer Investigational Site
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33703
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Pfizer Investigational Site
City
Seminole
State/Province
Florida
ZIP/Postal Code
33708
Country
United States
Facility Name
Pfizer Investigational Site
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351-6637
Country
United States
Facility Name
Pfizer Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Pfizer Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Pfizer Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Pfizer Investigational Site
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Pfizer Investigational Site
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Pfizer Investigational Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Pfizer Investigational Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Pfizer Investigational Site
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Pfizer Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
Pfizer Investigational Site
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
Pfizer Investigational Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Pfizer Investigational Site
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48917
Country
United States
Facility Name
Pfizer Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Pfizer Investigational Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Facility Name
Pfizer Investigational Site
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Pfizer Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Pfizer Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Pfizer Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Pfizer Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43124
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Pfizer Investigational Site
City
Mogadore
State/Province
Ohio
ZIP/Postal Code
44260
Country
United States
Facility Name
Pfizer Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Pfizer Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Pfizer Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Pfizer Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Pfizer Investigational Site
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Pfizer Investigational Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Pfizer Investigational Site
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15904
Country
United States
Facility Name
Pfizer Investigational Site
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17055
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19115
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15218
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Pfizer Investigational Site
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19464
Country
United States
Facility Name
Pfizer Investigational Site
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611-1124
Country
United States
Facility Name
Pfizer Investigational Site
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Pfizer Investigational Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Pfizer Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Pfizer Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Pfizer Investigational Site
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Facility Name
Pfizer Investigational Site
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-4548
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Pfizer Investigational Site
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Facility Name
Pfizer Investigational Site
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Pfizer Investigational Site
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
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=A0081057&StudyName=An+Open%2DLabel+Trial+of+Pregabalin+in+Patients+with+Fibromyalgia+++
Description
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Learn more about this trial

An Open-Label Trial of Pregabalin in Patients With Fibromyalgia

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