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Safety and Efficacy Study of Pregabalin in Fibromyalgia

Last updated on December 16, 2017

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.
Show details

- 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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Safety and Efficacy Study of Pregabalin in Fibromyalgia
A Six-Month, Double-Blind, Placebo Controlled, Durability of Effect Study of Pregabalin for Pain Associated With Fibromyalgia
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Fibromyalgia
  • Drug: pregabalin
  • Drug: placebo
Not Provided
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.
 
Completed
1020
June 2006
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00151489
A0081059
Not Provided
Not Provided
Not Provided
Director, Clinical Trials Disclosure Group, Pfizer, Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2006

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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