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NCT00282997 Clinical Trial

A Safety Study Of Pregabalin In Fibromyalgia

Fibromyalgia Clinical Trial

Official title:
A 12-Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00282997
Other study ID # A0081078
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 2006
Est. completion date October 2006

Study information
Verified date October 2007
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the safety of pregabalin in patients with fibromyalgia.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites. - Patients must complete the double-blind study. Exclusion Criteria: - Patients who experienced a serious adverse event during the previous fibromyalgia study, which was determined to be related to the study medication.

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 Asheville North Carolina
United States Pfizer Investigational Site Bedford Texas
United States Pfizer Investigational Site Bethlehem Pennsylvania
United States Pfizer Investigational Site Chaska Minnesota
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Dayton Ohio
United States Pfizer Investigational Site DeLand Florida
United States Pfizer Investigational Site Dubuque Iowa
United States Pfizer Investigational Site Endwell New York
United States Pfizer Investigational Site Everett Washington
United States Pfizer Investigational Site Fresno California
United States Pfizer Investigational Site Gainesville Florida
United States Pfizer Investigational Site Georgetown Texas
United States Pfizer Investigational Site Goose Creek South Carolina
United States Pfizer Investigational Site Gurnee Illinois
United States Pfizer Investigational Site Hickory North Carolina
United States Pfizer Investigational Site Hollywood Florida
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Jefferson City Missouri
United States Pfizer Investigational Site Kansas City Missouri
United States Pfizer Investigational Site Kenner Louisiana
United States Pfizer Investigational Site Killeen Texas
United States Pfizer Investigational Site Knoxville Tennessee
United States Pfizer Investigational Site La Jolla California
United States Pfizer Investigational Site Lake Jackson Texas
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Lincoln Nebraska
United States Pfizer Investigational Site Little Rock Arkansas
United States Pfizer Investigational Site Melbourne Florida
United States Pfizer Investigational Site Metairie Louisiana
United States Pfizer Investigational Site Milan Tennessee
United States Pfizer Investigational Site Milwaukee Wisconsin
United States Pfizer Investigational Site Minot North Dakota
United States Pfizer Investigational Site Moline Illinois
United States Pfizer Investigational Site Morristown New Jersey
United States Pfizer Investigational Site Mount Pleasant South Carolina
United States Pfizer Investigational Site Myrtle Beach South Carolina
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Newark Delaware
United States Pfizer Investigational Site Norristown Pennsylvania
United States Pfizer Investigational Site North Dartmouth Massachusetts
United States Pfizer Investigational Site Northridge California
United States Pfizer Investigational Site Ocala Florida
United States Pfizer Investigational Site Palm Harbor Florida
United States Pfizer Investigational Site Pismo Beach California
United States Pfizer Investigational Site Prairie Village Kansas
United States Pfizer Investigational Site Pratt Kansas
United States Pfizer Investigational Site Raleigh North Carolina
United States Pfizer Investigational Site Sacramento California
United States Pfizer Investigational Site Saint Louis Missouri
United States Pfizer Investigational Site Saint Paul Minnesota
United States Pfizer Investigational Site Salisbury North Carolina
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Spokane Washington
United States Pfizer Investigational Site Summerville South Carolina
United States Pfizer Investigational Site Sunrise Florida
United States Pfizer Investigational Site Tacoma Washington
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Tulsa Oklahoma
United States Pfizer Investigational Site Virginia Beach Virginia
United States Pfizer Investigational Site Walnut Creek California
United States Pfizer Investigational Site Watertown Massachusetts
United States Pfizer Investigational Site West Palm Beach Florida
United States Pfizer Investigational Site West Seneca New York
United States Pfizer Investigational Site Winston-Salem North Carolina
United States Pfizer Investigational Site Woodstock Vermont
United States Pfizer Investigational Site Worcester Massachusetts

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 To evaluate the safety of pregabalin in patients with fibromyalgia
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05659862 - Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia N/A
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 NCT03166995 - Postural Exercises in Women With Fibromyalgia N/A
Completed NCT03227952 - Sensory Stimulation in 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 NCT04571853 - New Educational Tool for FM N/A
Recruiting NCT04571528 - Effectiveness of VIRTUAL FIBROWALK STUDY N/A

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