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A Trial Assessing The Effectiveness and Safety of [S,S]-Reboxetine in Patients With Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00357825
First received: July 26, 2006
Last updated: May 14, 2013
Last verified: May 2013
History of Changes

July 26, 2006
May 14, 2013
August 2006
March 2007   (final data collection date for primary outcome measure)
Weekly Average Pain Score from the Daily Pain Diary.
Same as current
Complete list of historical versions of study NCT00357825 on ClinicalTrials.gov Archive Site
  • 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
  • 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 Questionaire (SF-MPQ)
  • Fibromyalgia Health Assessment Questionnaire (F-HAQ)
  • Safety and Tolerability
  • Exposure Response Relationship Between Daily Dose and Daily Pain Score
Not Provided
Not Provided
 
A Trial Assessing The Effectiveness and Safety of [S,S]-Reboxetine in Patients With Fibromyalgia
An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study of [S,S]-Reboxetine Administered Once Daily in Patients With Fibromyalgia

The purpose of this study is to assess the safety and effectiveness of [S,S]-Reboxetine in patients with fibromyalgia.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pain
Drug: [S,S]-Reboxetine
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
246
March 2007
March 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00357825
A6061034
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

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