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Trial record 1 of 1 for:    NCT00754221
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Open Label Extension Study of [S,S]-Reboxetine in Patients With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00754221
Recruitment Status : Terminated (This study has been terminated early as the esreboxetine development program is being discontinued. There are no safety or efficacy concerns.)
First Posted : September 17, 2008
Last Update Posted : June 1, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 16, 2008
First Posted Date  ICMJE September 17, 2008
Last Update Posted Date June 1, 2011
Study Start Date  ICMJE May 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2008)
  • Vital Signs [ Time Frame: 66 weeks ]
  • 12-Lead ECG [ Time Frame: 66 weeks ]
  • Hematology & Biochemistry Laboratory Parameters [ Time Frame: 66 weeks ]
  • Adverse Events [ Time Frame: 66 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00754221 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2009)
  • Short-Form 36 Health Survey [ Time Frame: 66 weeks ]
  • Sheehan Disability Scale [ Time Frame: 66 weeks ]
  • Pain Visual Analogue Scale [ Time Frame: 66 weeks ]
  • Multidimensional Assessment of Fatigue [ Time Frame: 66 weeks ]
  • Fibromyalgia Impact Questionaire [ Time Frame: 66 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2008)
  • Pain Visual Analogue Scale [ Time Frame: 66 weeks ]
  • Multidimensional Assessment of Fatigue [ Time Frame: 66 weeks ]
  • Fibromyalgia Impact Questionaire [ Time Frame: 66 weeks ]
  • Short-Form 36 Health Survey [ Time Frame: 66 weeks ]
  • Sheehan Disability Scale [ Time Frame: 66 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Summary This is a study to investigate the long-term safety and effectiveness [S,S]-Reboxetine in relieving the symptoms of Fibromyalgia in patients.
Detailed Description Not 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 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)
  • 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 Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2011

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