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

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NCT00612170

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35242, United States
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Contact
1-800-718-1021
[email protected]
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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2009)		1129
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2008)		1148
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 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)

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 NCT00612170
Other Study ID Numbers  ICMJE A6061043
A6061043
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP