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

NCT ID: NCT00346034

Last Updated: 2021-01-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

357 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

150 to 600mg/day

Interventions

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Pregabalin

150 to 600mg/day

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Kelowna, British Columbia, Canada

Site Status

Pfizer Investigational Site

Winnipeg, Manitoba, Canada

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Bathurst, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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Hawkesbury, Ontario, Canada

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Toronto, Ontario, Canada

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Drummondville, Quebec, Canada

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Montreal, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Québec, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Frederiksberg, , Denmark

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Svendborg, , Denmark

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Montpellier, Cedex 5, France

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Lille, Cedex, France

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Clermont-Ferrand, , France

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Paris, , France

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Saint-Priest-en-Jarez, , France

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Berlin, , Germany

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Berlin, , Germany

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Mannheim, , Germany

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München, , Germany

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Indore, Madhya Pradesh, India

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Ludhiana, Punjab, India

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Ludhiana, Punjab, India

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Lucknow, Uttar Pradesh, India

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Bari, , Italy

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Benevento, , Italy

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Bologna, , Italy

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Chieti Scalo, , Italy

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Pisa, , Italy

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Alkmaar, , Netherlands

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Den Helder, , Netherlands

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Leeuwarden, , Netherlands

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Zwolle, , Netherlands

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Lisbon, , Portugal

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Suwon, Kyeongki-do, South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Linköping, , Sweden

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Mölndal, , Sweden

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Örebro, , Sweden

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Stockholm, , Sweden

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Zurich, , Switzerland

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Zurich, , Switzerland

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Manchester, Greater Manchester, United Kingdom

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Greenock, Renfrewshire, United Kingdom

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North Shields, Tyne and Wear, United Kingdom

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London, , United Kingdom

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Pfizer Investigational Site

Poole, , United Kingdom

Site Status

Countries

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Canada Denmark France Germany India Italy Netherlands Portugal South Korea Sweden Switzerland United Kingdom

References

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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.

Reference Type DERIVED
PMID: 22503162 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

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

To obtain contact information for a study center near you, click here.

Other Identifiers

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A0081101

Identifier Type: -

Identifier Source: org_study_id

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