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NCT00151528 Clinical Trial

An Open-Label Trial of Pregabalin in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:
A Long-Term, Open-Label, Safety Trial of Pregabalin in Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00151528
Other study ID # A0081057
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2005
Est. completion date June 2006

Study information
Verified date July 2006
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 428
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pregabalin

Locations
Country Name City State
United States Pfizer Investigational Site Albany New York
United States Pfizer Investigational Site Altoona Pennsylvania
United States Pfizer Investigational Site Anderson South Carolina
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Beverly Hills California
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Charleston South Carolina
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Clearwater Florida
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Danbury Connecticut
United States Pfizer Investigational Site Decatur Georgia
United States Pfizer Investigational Site Duncansville Pennsylvania
United States Pfizer Investigational Site Eugene Oregon
United States Pfizer Investigational Site Greer South Carolina
United States Pfizer Investigational Site Hot Springs Arkansas
United States Pfizer Investigational Site Huntsville Alabama
United States Pfizer Investigational Site Johnstown Pennsylvania
United States Pfizer Investigational Site Kalamazoo Michigan
United States Pfizer Investigational Site Kansas City Missouri
United States Pfizer Investigational Site Kansas City Kansas
United States Pfizer Investigational Site Lansing Michigan
United States Pfizer Investigational Site Lebanon New Hampshire
United States Pfizer Investigational Site Little Rock Arkansas
United States Pfizer Investigational Site Los Alamitos California
United States Pfizer Investigational Site Lubbock Texas
United States Pfizer Investigational Site Madisonville Kentucky
United States Pfizer Investigational Site Maywood Illinois
United States Pfizer Investigational Site Mechanicsburg Pennsylvania
United States Pfizer Investigational Site Medford Oregon
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Mogadore Ohio
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New Milford Connecticut
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Newport Beach California
United States Pfizer Investigational Site Newton Massachusetts
United States Pfizer Investigational Site Northridge California
United States Pfizer Investigational Site Oak Brook Illinois
United States Pfizer Investigational Site Ocala Florida
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Palm Beach Gardens Florida
United States Pfizer Investigational Site Peoria Illinois
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Pismo Beach California
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Pottstown Pennsylvania
United States Pfizer Investigational Site Princeton New Jersey
United States Pfizer Investigational Site Redondo Beach California
United States Pfizer Investigational Site Richardson Texas
United States Pfizer Investigational Site Riverside California
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site Saint Petersburg Florida
United States Pfizer Investigational Site Saint Petersburg Florida
United States Pfizer Investigational Site Saint Petersburg Florida
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site Scottsdale Arizona
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Seminole Florida
United States Pfizer Investigational Site Stratford Connecticut
United States Pfizer Investigational Site Sunrise Florida
United States Pfizer Investigational Site Toledo Ohio
United States Pfizer Investigational Site Virginia Beach Virginia
United States Pfizer Investigational Site Walnut Creek California
United States Pfizer Investigational Site West Palm Beach Florida
United States Pfizer Investigational Site West Reading Pennsylvania
United States Pfizer Investigational Site Whittier California
United States Pfizer Investigational Site Wilmington North Carolina
United States Pfizer Investigational Site Wilmington North Carolina
United States Pfizer Investigational Site Winston-Salem North Carolina
United States Pfizer Investigational Site Woodstock Vermont
United States Pfizer Investigational Site Wyomissing Pennsylvania
United States Pfizer Investigational Site Yakima Washington

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 There are no secondary outcome measures
See also
  Status Clinical Trial Phase
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Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT03042728 - Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program N/A
Recruiting NCT06097091 - Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia N/A
Recruiting NCT04554784 - Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia N/A
Completed NCT03300635 - Metabolism, Muscle Function and Psychological Factors in Fibromyalgia N/A
Recruiting NCT06166563 - Exercise, Irritable Bowel Syndrome and Fibromyalgia N/A
Completed NCT03227952 - Sensory Stimulation in Fibromyalgia N/A
Completed NCT03166995 - Postural Exercises in Women With Fibromyalgia N/A
Recruiting NCT06237595 - Vagus Nerve Stimulation in Fibromyalgia N/A
Completed NCT01888640 - Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST) N/A
Completed NCT03641495 - Pain Education and Therapeutic Exercise for Fibromyalgia N/A
Recruiting NCT05581628 - FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Active, not recruiting NCT05128162 - Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia Phase 2
Completed NCT04674878 - Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia N/A
Active, not recruiting NCT04084795 - Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia N/A
Completed NCT03129906 - Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients N/A
Completed NCT05058911 - Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia N/A
Recruiting NCT04571528 - Effectiveness of VIRTUAL FIBROWALK STUDY N/A
Recruiting NCT04571853 - New Educational Tool for FM N/A

External Links