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This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 3
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

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 A0081100, and 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 A0081100 which was determined to be related to the study medication by the investigator or the sponsor.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score
Mean Change: Observation VAS score minus Baseline score. Pain VAS: 100 mm horizontal line to rate (score) pain from 0 "no pain" to 100 "worst possible pain". Baseline = value @ double-blind screening if randomized to pregabalin during double-blind or value @ last visit from double-blind if randomized to placebo during double-blind.
Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score
Mean Change: Observation VAS score minus Baseline score. Pain VAS is a 100mm horizontal line used to rate (score) pain by subject from 0 "no pain" to 100 "worst possible pain". Baseline=value @ double-blind screening if randomized to pregabalin during double-blind OR value @ last visit from double-blind if randomized to placebo during double-blind.

Secondary Outcome Measures

Full Information

First Posted
June 28, 2006
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
NCT00346034
Brief Title
This Study is An Open-Label Trial Of Pregabalin In Patients With 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
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (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
No

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 A0081100 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
357 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
150 to 600mg/day
Primary Outcome Measure Information:
Title
Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score
Description
Mean Change: Observation VAS score minus Baseline score. Pain VAS: 100 mm horizontal line to rate (score) pain from 0 "no pain" to 100 "worst possible pain". Baseline = value @ double-blind screening if randomized to pregabalin during double-blind or value @ last visit from double-blind if randomized to placebo during double-blind.
Time Frame
Week 4
Title
Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score
Description
Mean Change: Observation VAS score minus Baseline score. Pain VAS is a 100mm horizontal line used to rate (score) pain by subject from 0 "no pain" to 100 "worst possible pain". Baseline=value @ double-blind screening if randomized to pregabalin during double-blind OR value @ last visit from double-blind if randomized to placebo during double-blind.
Time Frame
Week 12 (end of treatment)

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 A0081100, and 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 A0081100 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
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 2H4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Bathurst
State/Province
New Brunswick
ZIP/Postal Code
E2A 4X7
Country
Canada
Facility Name
Pfizer Investigational Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3E1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hawkesbury
State/Province
Ontario
ZIP/Postal Code
K6A 1A1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3K 2A7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 7T1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Pointe Claire
State/Province
Quebec
ZIP/Postal Code
H9R 3J1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Montpellier
State/Province
Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Pfizer Investigational Site
City
Lille
State/Province
Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Pfizer Investigational Site
City
Clermont Ferrand Cedex 1
ZIP/Postal Code
63003
Country
France
Facility Name
Pfizer Investigational Site
City
Paris Cedex 04
ZIP/Postal Code
75181
Country
France
Facility Name
Pfizer Investigational Site
City
Saint Priest En Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
14109
Country
Germany
Facility Name
Pfizer Investigational Site
City
Mannheim
ZIP/Postal Code
68161
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Pfizer Investigational Site
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452001
Country
India
Facility Name
Pfizer Investigational Site
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141 001
Country
India
Facility Name
Pfizer Investigational Site
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141 008
Country
India
Facility Name
Pfizer Investigational Site
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226 014
Country
India
Facility Name
Pfizer Investigational Site
City
Bari
ZIP/Postal Code
79124
Country
Italy
Facility Name
Pfizer Investigational Site
City
Benevento
ZIP/Postal Code
82100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Pfizer Investigational Site
City
Chieti Scalo
ZIP/Postal Code
66013
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pisa
Country
Italy
Facility Name
Pfizer Investigational Site
City
Suwon-si
State/Province
Kyeongki-do
ZIP/Postal Code
442-712
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
133-792
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
143-914
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Den Helder
ZIP/Postal Code
1782 GZ
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Zwolle
ZIP/Postal Code
8011 JW
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Lisbon
ZIP/Postal Code
1700-360
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Linkoping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Molndal
ZIP/Postal Code
431 37
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Orebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
SE-112 81
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Zürich
ZIP/Postal Code
8063
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Greenock
State/Province
Renfrewshire
ZIP/Postal Code
PA16 0XN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
North Shields
State/Province
Tyne And Wear
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
WC1X 8LD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Poole
ZIP/Postal Code
BH12 2JB
Country
United Kingdom

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=A0081101&StudyName=This%20Study%20is%20An%20Open-Label%20Trial%20Of%20Pregabalin%20In%20Patients%20With%20Fibromyalgia%20%20%20
Description
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Learn more about this trial

This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia

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