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Open Label Extension Study of [S,S]-Reboxetine in Patients With Fibromyalgia

Last updated on November 14, 2019

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35242 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.
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- Male or female of any race, at least 18 years of age

- 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)

- Completed preceding double-blind randomized, controlled trial

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

- Patients with other severe pain (eg, Diabetic Peripheral Neuropathy and PostHerpetic
Neuralgia) that may confound assessment or self evaluation of the pain associated
with fibromyalgia

- Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other
than fibromyalgia), active infection, or untreated endocrine disorder

- A current or recent diagnosis (last 6 months) or episode of major depressive
disorder, dysthymia and/or uncontrolled depression

- History of mania, hypomania, other psychotic disorder, or current mood disorder with
psychotic features

NCT00754221
Pfizer
Terminated
Open Label Extension Study of [S,S]-Reboxetine in Patients With Fibromyalgia

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Descriptive Information
Brief Title  ICMJE Open Label Extension Study of [S,S]-Reboxetine in Patients With Fibromyalgia
Official Title  ICMJE A Multi-center, Long-term, Open-label Extension Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia
Brief SummaryThis is a study to investigate the long-term safety and effectiveness [S,S]-Reboxetine in relieving the symptoms of Fibromyalgia in patients.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE Drug: [S,S]-Reboxetine
Once a day, oral treatment, of 4, 6, 8 or 10 mg
Study Arms  ICMJE Experimental: 1
Intervention: Drug: [S,S]-Reboxetine
Publications *Not Provided


*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: May 31, 2011)
390
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2008)
800
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion DateMay 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female of any race, at least 18 years of age
  • 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)
  • Completed preceding double-blind randomized, controlled trial

Exclusion Criteria:

  • Patients with other severe pain (eg, Diabetic Peripheral Neuropathy and PostHerpetic Neuralgia) that may confound assessment or self evaluation of the pain associated with fibromyalgia
  • Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), active infection, or untreated endocrine disorder
  • A current or recent diagnosis (last 6 months) or episode of major depressive disorder, dysthymia and/or uncontrolled depression
  • History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features
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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00754221
Other Study ID Numbers  ICMJE A6061053
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2011

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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