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A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294 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

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

- Patients who completed at least 4 pain diaries within the last 7 days and the average
pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale
(VAS) of the SF-MPQ at screening (Visit 1) and randomization (Visit 2)

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

- Patients with other severe pain that may confound assessment or self-evaluation of the
pain associated with fibromyalgia

- Patients with any inflammatory muscle or rheumatologic disease other than
fibromyalgia, active infections, or untreated endocrine disorders

- Patients with severe depression

NCT00645398
Pfizer
Completed
A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia

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A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia
A 13-Week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Trial of Pregabalin (BID) in Patients With Fibromyalgia
The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance associated with fibromyalgia.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Fibromyalgia
  • Drug: Pregabalin
    Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
  • Drug: Pregabalin
    Pregabalin 150 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
  • Drug: Pregabalin
    Pregabalin 300 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
  • Drug: Placebo
    Matching placebo capsules taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
  • Experimental: A
    Intervention: Drug: Pregabalin
  • Experimental: B
    Intervention: Drug: Pregabalin
  • Experimental: C
    Intervention: Drug: Pregabalin
  • Placebo Comparator: D
    Intervention: Drug: Placebo


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
751
June 2005
Not Provided

Inclusion Criteria:

  • Patients who met the American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
  • Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ?4, and had a score of ?40 mm on the Visual Analogue Scale (VAS) of the SF-MPQ at screening (Visit 1) and randomization (Visit 2)

Exclusion Criteria:

  • Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia
  • Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders
  • Patients with severe depression
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
 
 
NCT00645398
A0081056
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

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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1-800-718-1021

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Contact

[email protected]



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