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A Study For Pregabalin In Patients With Fibromyalgia

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Department of Rheumatism And Immunity, The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233000 China
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

- Male or female patients, at least 18 years of age

- Meeting the ACR (America College of Rheumatology) criteria for fibromyalgia (ie,
widespread pain present for at least 3 months, and pain in at least 11 of 18 specific
tender point sites)

- At screening (V1) and randomization (V2), patients must have a score of no less than
40 mm on the Pain Visual Analog Scale (VAS)

- At randomization (V2), at least 4 pain diaries must be completed satisfactorily within
the last 7 days and the average pain score must be no less than 4

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients with no less than 30% decrease on the Pain Visual Analog Scale (VAS) at
randomization (V2) as compared to screening (V1)

- Patients with other severe pain due to other conditions (eg, DPN or PHN) that may
confound assessment or self-evaluation of the pain associated with fibromyalgia

- Patients with any widespread inflammatory musculoskeletal disorders, widespread
rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine
disorders

- CLcr less than 60 mL/min (estimated from serum creatinine)

NCT01387607
Pfizer
Completed
A Study For Pregabalin In Patients With Fibromyalgia

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A Study For Pregabalin In Patients With Fibromyalgia
A 14-week, Randomized, Double-blind Placebo-controlled Study For Pregabalin In Subjects With Fibromyalgia
The purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared with placebo for management of fibromyalgia in adults.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Fibromyalgia
  • Drug: pregabalin
    Pregabalin capsule, 300-450mg/day, twice daily
  • Drug: placebo
    Placebo, twice daily
  • Experimental: Pregabalin
    Intervention: Drug: pregabalin
  • Placebo Comparator: Placebo
    Matched placebo
    Intervention: Drug: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
343
October 2016
October 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female patients, at least 18 years of age
  • Meeting the ACR (America College of Rheumatology) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
  • At screening (V1) and randomization (V2), patients must have a score of no less than 40 mm on the Pain Visual Analog Scale (VAS)
  • At randomization (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be no less than 4

Exclusion Criteria:

  • Patients with no less than 30% decrease on the Pain Visual Analog Scale (VAS) at randomization (V2) as compared to screening (V1)
  • Patients with other severe pain due to other conditions (eg, DPN or PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia
  • Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders
  • CLcr less than 60 mL/min (estimated from serum creatinine)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01387607
A0081241
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

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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