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A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.

Last updated on May 10, 2018

FOR MORE INFORMATION
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.
Show details

- 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)

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

NCT00612170
Pfizer
Completed
A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.

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[email protected]

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A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.
A 14-week, Randomized, Double-blind, Placebo-controlled, Multi-center Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily (O.D.) in Patients With Fibromyalgia
This is a study to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving the symptoms of Fibromyalgia in patients. A previous study demonstrated clinically meaningful treatment effects in fibromyalgia, based on pain and functional endpoints.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Fibromyalgia
  • Drug: [S,S]-Reboxetine
    10 mg oral tablet once a day dosing
  • Drug: Placebo
    0 mg oral tablet once a day dosing
  • Drug: [S,S]-Reboxetine
    4 mg oral tablet once a day dosing
  • Drug: [S,S]-Reboxetine
    8 mg oral tablet once a day dosing
  • Experimental: 3
    Intervention: Drug: [S,S]-Reboxetine
  • Sham Comparator: 4
    Intervention: Drug: Placebo
  • Experimental: 1
    Intervention: Drug: [S,S]-Reboxetine
  • Experimental: 2
    Intervention: Drug: [S,S]-Reboxetine
Arnold LM, Hirsch I, Sanders P, Ellis A, Hughes B. Safety and efficacy of esreboxetine in patients with fibromyalgia: a fourteen-week, randomized, double-blind, placebo-controlled, multicenter clinical trial. Arthritis Rheum. 2012 Jul;64(7):2387-97. doi: 10.1002/art.34390.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1129
May 2009
May 2009   (Final data collection date for primary outcome measure)

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)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00612170
A6061043
A6061043
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 2011

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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[email protected]



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