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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

357

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Dec 2006

Shorter than P25 for phase_3

Geographic Reach

12 countries

51 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

June 28, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2006

Completed

5 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

March 13, 2009

Completed

Last Updated

January 22, 2021

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

June 28, 2006

Results QC Date

February 12, 2009

Last Update Submit

January 20, 2021

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (2)

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.
Week 4
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.
Week 12 (end of treatment)

Study Arms (1)

1

EXPERIMENTAL

Drug: Pregabalin

Interventions

PregabalinDRUG

150 to 600mg/day

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Study Sites (51)

Pfizer Investigational Site

Kelowna, British Columbia, V1Y 2H4, Canada

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Pfizer Investigational Site

Bathurst, New Brunswick, E2A 4X7, Canada

Location

Pfizer Investigational Site

St. John's, Newfoundland and Labrador, A1B 3E1, Canada

Location

Pfizer Investigational Site

Hawkesbury, Ontario, K6A 1A1, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M3K 2A7, Canada

Location

Pfizer Investigational Site

Drummondville, Quebec, J2B 7T1, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H3T 1E2, Canada

Location

Pfizer Investigational Site

Pointe-Claire, Quebec, H9R 3J1, Canada

Location

Pfizer Investigational Site

Québec, Quebec, G1V 3M7, Canada

Location

Pfizer Investigational Site

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Pfizer Investigational Site

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Pfizer Investigational Site

Frederiksberg, 2000, Denmark

Location

Pfizer Investigational Site

Svendborg, 5700, Denmark

Location

Pfizer Investigational Site

Montpellier, Cedex 5, 34295, France

Location

Pfizer Investigational Site

Lille, Cedex, 59037, France

Location

Pfizer Investigational Site

Clermont-Ferrand, 63003, France

Location

Pfizer Investigational Site

Paris, 75181, France

Location

Pfizer Investigational Site

Saint-Priest-en-Jarez, 42270, France

Location

Pfizer Investigational Site

Berlin, 10117, Germany

Location

Pfizer Investigational Site

Berlin, 14109, Germany

Location

Pfizer Investigational Site

Mannheim, 68161, Germany

Location

Pfizer Investigational Site

München, 80336, Germany

Location

Pfizer Investigational Site

Indore, Madhya Pradesh, 452001, India

Location

Pfizer Investigational Site

Ludhiana, Punjab, 141 001, India

Location

Pfizer Investigational Site

Ludhiana, Punjab, 141 008, India

Location

Pfizer Investigational Site

Lucknow, Uttar Pradesh, 226 014, India

Location

Pfizer Investigational Site

Bari, 79124, Italy

Location

Pfizer Investigational Site

Benevento, 82100, Italy

Location

Pfizer Investigational Site

Bologna, 40138, Italy

Location

Pfizer Investigational Site

Chieti Scalo, 66013, Italy

Location

Pfizer Investigational Site

Pisa, Italy

Location

Pfizer Investigational Site

Alkmaar, 1815 JD, Netherlands

Location

Pfizer Investigational Site

Den Helder, 1782 GZ, Netherlands

Location

Pfizer Investigational Site

Leeuwarden, 8934 AD, Netherlands

Location

Pfizer Investigational Site

Zwolle, 8011 JW, Netherlands

Location

Pfizer Investigational Site

Lisbon, 1700-360, Portugal

Location

Pfizer Investigational Site

Suwon, Kyeongki-do, 442-712, South Korea

Location

Pfizer Investigational Site

Seoul, 133-792, South Korea

Location

Pfizer Investigational Site

Seoul, 143-914, South Korea

Location

Pfizer Investigational Site

Linköping, 581 85, Sweden

Location

Pfizer Investigational Site

Mölndal, 431 37, Sweden

Location

Pfizer Investigational Site

Örebro, 701 85, Sweden

Location

Pfizer Investigational Site

Stockholm, SE-112 81, Sweden

Location

Pfizer Investigational Site

Zurich, 8063, Switzerland

Location

Pfizer Investigational Site

Zurich, 8091, Switzerland

Location

Pfizer Investigational Site

Manchester, Greater Manchester, M6 8HD, United Kingdom

Location

Pfizer Investigational Site

Greenock, Renfrewshire, PA16 0XN, United Kingdom

Location

Pfizer Investigational Site

North Shields, Tyne and Wear, NE29 8NH, United Kingdom

Location

Pfizer Investigational Site

London, WC1X 8LD, United Kingdom

Location

Pfizer Investigational Site

Poole, BH12 2JB, United Kingdom

Location

Related Publications (1)

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.
PMID: 22503162DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.

Study Officials

Pfizer CT.gov Call Center
Pfizer
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 28, 2006

First Posted

June 29, 2006

Study Start

December 1, 2006

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

January 22, 2021

Results First Posted

March 13, 2009

Record last verified: 2018-11

Locations

NL(4)PT(1)IN(4)IT(5)CH(2)FR(5)DE(4)KR(3)SE(4)GB(5)CA(12)DK(2)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (51)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (51)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations