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Safety and Efficacy Study of Pregabalin in Fibromyalgia

Last updated on November 17, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fibromyalgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00151489
Pfizer
Completed
Safety and Efficacy Study of Pregabalin in Fibromyalgia

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Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Pregabalin in Fibromyalgia
Official Title  ICMJE A Six-Month, Double-Blind, Placebo Controlled, Durability of Effect Study of Pregabalin for Pain Associated With Fibromyalgia
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Drug: pregabalin
  • Drug: placebo
Study Arms  ICMJE Not Provided
Publications *Pauer L, Atkinson G, Murphy TK, Petersel D, Zeiher B. Long-term maintenance of response across multiple fibromyalgia symptom domains in a randomized withdrawal study of pregabalin. Clin J Pain. 2012 Sep;28(7):609-14. doi: 10.1097/AJP.0b013e31823dd315.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 7, 2005)
1020
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2006
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00151489
Other Study ID Numbers  ICMJE A0081059
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trials Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2006

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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