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Trial record 1 of 1 for:    NCT00612170
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A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.

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ClinicalTrials.gov Identifier: NCT00612170
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 29, 2008
First Posted Date  ICMJE February 11, 2008
Last Update Posted Date December 12, 2019
Study Start Date  ICMJE December 2007
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2009)
  • Change from baseline in the endpoint mean pain score [ Time Frame: 14 weeks ]
  • Fibromyalgia Impact Questionnaire [ Time Frame: 14 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2008)
  • Multidimensional Assessment of Fatigure [ Time Frame: 14 weeks ]
  • Change from baseline in the endpoint mean pain score [ Time Frame: 14 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
  • Change from baseline in the endpoint mean sleep interference score [ Time Frame: 14 weeks ]
  • Patient Global Impression of Change [ Time Frame: 14 weeks ]
  • Multidimensional Assessment of Fatigue [ Time Frame: 14 weeks ]
  • Hospital Anxiety and Depression Scale [ Time Frame: 14 weeks ]
  • Short Form 36 [ Time Frame: 14 weeks ]
  • Sheehan Disability Score [ Time Frame: 14 weeks ]
  • Pain Visual Analogue Scale [ Time Frame: 14 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2008)
  • Change from baseline in the endpoint mean sleep intereference score [ Time Frame: 14 weeks ]
  • Patient Global Impression of Change [ Time Frame: 14 weeks ]
  • Fibromylagia Impact Questionnaire [ Time Frame: 14 weeks ]
  • Hospital Anxiety and Depression Scale [ Time Frame: 14 weeks ]
  • Short Form 36 [ Time Frame: 14 weeks ]
  • Sheehan Disability Score [ Time Frame: 14 weeks ]
  • Pain Visual Analogue Scale [ Time Frame: 14 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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