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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Brief Summary:
The purpose of this study is to assess the safety and effectiveness of [S,S]-Reboxetine in patients with fibromyalgia.

Condition or disease Intervention/treatment Phase
Pain Drug: [S,S]-Reboxetine Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study of [S,S]-Reboxetine Administered Once Daily in Patients With Fibromyalgia
Study Start Date : August 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources




Primary Outcome Measures :
  1. Weekly Average Pain Score from the Daily Pain Diary.

Secondary Outcome Measures :
  1. Fibromyalgia Impact Questionnaire (FIQ) Total Score
  2. Patient Global Impression of Change
  3. Short-Form 36 Health Survey (SF 36)
  4. Sheehan Disability Scale
  5. Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale)
  6. Quality of Sleep Score from the Daily Sleep Diary
  7. Multidimensional Assessment of Fatigue (MAF)
  8. Hospital Anxiety and Depression Scales (HADS)
  9. Short-Form McGill Pain Questionnaire (SF-MPQ)
  10. Fibromyalgia Health Assessment Questionnaire (F-HAQ)
  11. Safety and Tolerability
  12. Exposure Response Relationship Between Daily Dose and Daily Pain Score


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357825


  Show 61 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00357825     History of Changes
Other Study ID Numbers: A6061034
First Posted: July 28, 2006    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Fibromyalgia
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Reboxetine
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs