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Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Nagoya, Aichi, Japan
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

- ACR criteria for fibromyalgia

- A score of more or equal to 40 mm on the Pain VAS

- An average score more or equal to 4 on 4 daily pain diaries

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

- Patients with other severe pain conditions

- Patients with severe depression

- Patients taking excluded medications

- Patients with suicidality

NCT00830167
Pfizer
Completed
Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia
Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin?CI-1008?In The Treatment Of Fibromyalgia
This study, will compare pregabalin with placebo for the duration of 15 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Fibromyalgia
  • Drug: Placebo
    Dosage: placebo, oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)
  • Drug: Pregabalin
    Dosage: 300 or 450 mg/day (150 or 225 mg bid), oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Pregabalin
    Intervention: Drug: Pregabalin


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
498
May 2011
May 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ACR criteria for fibromyalgia
  • A score of more or equal to 40 mm on the Pain VAS
  • An average score more or equal to 4 on 4 daily pain diaries

Exclusion Criteria:

  • Patients with other severe pain conditions
  • Patients with severe depression
  • Patients taking excluded medications
  • Patients with suicidality
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00830167
A0081208
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2012

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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