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A Controlled Pregabalin Trial In Fibromyalgia

Last updated on November 17, 2019

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Study Location
Pfizer Investigational Site
Little Rock, Arkansas, 72205 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 must meet the 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 must have a score of >40 mm on the Visual Analog Scale

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

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

NCT00230776
Pfizer
Completed
A Controlled Pregabalin Trial In Fibromyalgia

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Descriptive Information
Brief Title  ICMJE A Controlled Pregabalin Trial In Fibromyalgia
Official Title  ICMJE A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia
Brief SummaryTo evaluate the efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of patients with fibromyalgia
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 *


*   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 29, 2005)
740
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2006
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must meet the 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 must have a score of >40 mm on the Visual Analog Scale

Exclusion Criteria:

  • Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders.
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 NCT00230776
Other Study ID Numbers  ICMJE A0081077
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 DateOctober 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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