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Trial record 1 of 1 for:    NCT00357825
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A Trial Assessing The Effectiveness and Safety of [S,S]-Reboxetine in Patients With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00357825
Recruitment Status : Completed
First Posted : July 28, 2006
Last Update Posted : May 15, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 26, 2006
First Posted Date  ICMJE July 28, 2006
Last Update Posted Date May 15, 2013
Study Start Date  ICMJE August 2006
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2006)
Weekly Average Pain Score from the Daily Pain Diary.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2006)
  • Fibromyalgia Impact Questionnaire (FIQ) Total Score
  • Patient Global Impression of Change
  • Short-Form 36 Health Survey (SF 36)
  • Sheehan Disability Scale
  • Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale)
  • Quality of Sleep Score from the Daily Sleep Diary
  • Multidimensional Assessment of Fatigue (MAF)
  • Hospital Anxiety and Depression Scales (HADS)
  • Short-Form McGill Pain Questionnaire (SF-MPQ)
  • Fibromyalgia Health Assessment Questionnaire (F-HAQ)
  • Safety and Tolerability
  • Exposure Response Relationship Between Daily Dose and Daily Pain Score
Original Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2006)
  • Fibromyalgia Impact Questionnaire (FIQ) Total Score
  • Patient Global Impression of Change
  • Short-Form 36 Helath Survey (SF 36)
  • Sheehan Disability Scale
  • Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale)
  • Quality of Sleep Score from the Daily Sleep Diary
  • Multidimensional Assessment of Fatigue (MAF)
  • Hospital Anxiety and Depression Scales (HADS)
  • Short-Form McGill Pain Questionnaire (SF-MPQ)
  • Fibromyalgia Health Assessment Questionnaire (F-HAQ)
  • Safety and Tolerability
  • Exposure Response Relationship Between Daily Dose and Daily Pain Score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial Assessing The Effectiveness and Safety of [S,S]-Reboxetine in Patients With Fibromyalgia
Official Title  ICMJE An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study of [S,S]-Reboxetine Administered Once Daily in Patients With Fibromyalgia
Brief Summary The purpose of this study is to assess the safety and effectiveness of [S,S]-Reboxetine in patients with fibromyalgia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE Drug: [S,S]-Reboxetine
Study Arms  ICMJE Not Provided
Publications * Arnold LM, Chatamra K, Hirsch I, Stoker M. Safety and efficacy of esreboxetine in patients with fibromyalgia: An 8-week, multicenter, randomized, double-blind, placebo-controlled study. Clin Ther. 2010 Aug;32(9):1618-32. doi: 10.1016/j.clinthera.2010.08.003.

*   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
Enrollment  ICMJE
 (submitted: July 26, 2006)
246
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At screening patients must meet the ACR criteria for fibromyalgia (i.e. widespread pain for at least 3 months, and pain in at least 11 of 18 specific tender point sites).
  • At screening and randomization, patients must have a score of >/=40mm on the Visual Analog Scale (VAS) of the Short-Form-McGill Pain Questionnaire (SF-MPQ).

Exclusion Criteria:

  • Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia.
  • Patients with severe hepatic impairment.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00357825
Other Study ID Numbers  ICMJE A6061034
Has Data Monitoring Committee Not Provided
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 May 2013

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