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NCT00151489 Clinical Trial

Safety and Efficacy Study of Pregabalin in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:
A Six-Month, Double-Blind, Placebo Controlled, Durability of Effect Study of Pregabalin for Pain Associated With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00151489
Other study ID # A0081059
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2005
Est. completion date June 2006

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

Clinical Trial Summary

The purpose of this research study of pregabalin and fibromyalgia is to see if 1. pregabalin reduces the pain of fibromyalgia and if this effect lasts for six months and 2. to see if different dosages work better (reduce pain and mild to no side effects) for different people.

Recruitment information / eligibility
Status Completed
Enrollment 1020
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - At screening (V1), patients must meet the American College of Rheumatology criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites - At Screen (V1) and enrollment (V2), patients must have a score of greater than 40 mm on the Pain Visual Analog Scale Exclusion Criteria: - Other severe pain or inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections or untreated endocrine disorders; or severe depression and other serious hepatic, respiratory, hematologic or immunologic illness or active malignancy or history of malignancy (examples of prohibited diseases: Hepatitis C, HIV, diabetes with nerve pain, other nerve pain (shingles), sleep apnea, epilepsy, narcolepsy, rheumatoid arthritis, generalized osteoarthritis, Lupus, Lyme disease unless sign and symptom free for 2 years, Sjogren's Syndrome, Sarcoid, Psoriatic Arthritis, Scleroderma) - Previous participation in a clinical trial with pregabalin; currently receiving or pending disability claims or workmans compensation or civil litigation, or used other experimental medicines within 30 days of screening - Creatinine Clearance less than 60 mL/min (estimated from serum creatinine; low platelet and/or white blood cell counts; abnormal Westergren erythrocyte sedimentation rate; abnormal antinuclear antibody (ANA greater than 3U), or rheumatoid factor (RF greater than 80 IU/mL); abnormal (clinically relevant 12 lead ECG) - Use of prohibited pain/sleep medications (including antidepressants, sedatives, hypnotics, NSAIDs, opiates, muscle relaxants) during the study. Washout required prior to study entry.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• pregabalin

• placebo

Locations
Country Name City State
United States Pfizer Investigational Site Albany New York
United States Pfizer Investigational Site Anaheim California
United States Pfizer Investigational Site Anniston Alabama
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Baton Rouge Louisiana
United States Pfizer Investigational Site Bensalem Pennsylvania
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Blue Springs Missouri
United States Pfizer Investigational Site Calera Alabama
United States Pfizer Investigational Site Carmichael California
United States Pfizer Investigational Site Charleston South Carolina
United States Pfizer Investigational Site Charleston West Virginia
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Cherry Hill New Jersey
United States Pfizer Investigational Site Chiefland Florida
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 Denver Colorado
United States Pfizer Investigational Site Edina Minnesota
United States Pfizer Investigational Site Edison New Jersey
United States Pfizer Investigational Site Eugene Oregon
United States Pfizer Investigational Site Evansville Indiana
United States Pfizer Investigational Site Evansville Indiana
United States Pfizer Investigational Site Fayetteville Arkansas
United States Pfizer Investigational Site Fort Worth Texas
United States Pfizer Investigational Site Fresno California
United States Pfizer Investigational Site Greenville South Carolina
United States Pfizer Investigational Site Greer South Carolina
United States Pfizer Investigational Site Gurnee Illinois
United States Pfizer Investigational Site Henderson Nevada
United States Pfizer Investigational Site Highland Park New Jersey
United States Pfizer Investigational Site Hot Springs Arkansas
United States Pfizer Investigational Site Huntsville Alabama
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Jackson Mississippi
United States Pfizer Investigational Site Johnson City New York
United States Pfizer Investigational Site Kalamazoo Michigan
United States Pfizer Investigational Site Kissimmee Florida
United States Pfizer Investigational Site Lansing Michigan
United States Pfizer Investigational Site Layton Utah
United States Pfizer Investigational Site Layton Utah
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Los Alamitos California
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 Miami Florida
United States Pfizer Investigational Site Mogadore Ohio
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site Newark Delaware
United States Pfizer Investigational Site Northridge California
United States Pfizer Investigational Site Ocala Florida
United States Pfizer Investigational Site Ocala Florida
United States Pfizer Investigational Site Owensboro Kentucky
United States Pfizer Investigational Site Palm Harbor Florida
United States Pfizer Investigational Site Palm Springs Florida
United States Pfizer Investigational Site Peoria Illinois
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 Plantation Florida
United States Pfizer Investigational Site Plantation Florida
United States Pfizer Investigational Site Prairie Village Kansas
United States Pfizer Investigational Site Raleigh North Carolina
United States Pfizer Investigational Site Raleigh North Carolina
United States Pfizer Investigational Site Ridgewood New Jersey
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site Saint Petersburg Florida
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 Antonio Texas
United States Pfizer Investigational Site Santa Ana California
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 Seattle Washington
United States Pfizer Investigational Site Sioux Falls South Dakota
United States Pfizer Investigational Site Smithtown New York
United States Pfizer Investigational Site South Eddison New Jersey
United States Pfizer Investigational Site South Jordan Utah
United States Pfizer Investigational Site Spokane Washington
United States Pfizer Investigational Site Springfield Missouri
United States Pfizer Investigational Site Springfield Massachusetts
United States Pfizer Investigational Site Stratford Connecticut
United States Pfizer Investigational Site Sunrise Florida
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Toledo Ohio
United States Pfizer Investigational Site Tulsa Oklahoma
United States Pfizer Investigational Site Tuscaloosa Alabama
United States Pfizer Investigational Site Virginia Beach Virginia
United States Pfizer Investigational Site Virginia Beach Virginia
United States Pfizer Investigational Site Walnut Creek California
United States Pfizer Investigational Site Washington District of Columbia
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 Winston-Salem North Carolina
United States Pfizer Investigational Site Worcester Massachusetts
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 To evaluate the efficacy of pregabalin (BID) compared with placebo in assessing the durability of effect for the treatment of pain associated with fibromyalgia among patients who initially respond to open-label pregabalin using Pain Visual Analog Scale
Secondary To evaluate the efficacy of pregabalin (BID) compared with placebo treatment to relieve pain and to improve global assessment, functional status, sleep and fatigue associated with fibromyalgia using questionnaires. To evaluate the longterm safety
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 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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