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A 14-week, Multi-center Study 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: NCT00612170
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : December 12, 2019
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: [S,S]-Reboxetine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: 3 Drug: [S,S]-Reboxetine
10 mg oral tablet once a day dosing

Sham Comparator: 4 Drug: Placebo
0 mg oral tablet once a day dosing

Experimental: 1 Drug: [S,S]-Reboxetine
4 mg oral tablet once a day dosing

Experimental: 2 Drug: [S,S]-Reboxetine
8 mg oral tablet once a day dosing

Primary Outcome Measures :
  1. Change from baseline in the endpoint mean pain score [ Time Frame: 14 weeks ]
  2. Fibromyalgia Impact Questionnaire [ Time Frame: 14 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in the endpoint mean sleep interference score [ Time Frame: 14 weeks ]
  2. Patient Global Impression of Change [ Time Frame: 14 weeks ]
  3. Multidimensional Assessment of Fatigue [ Time Frame: 14 weeks ]
  4. Hospital Anxiety and Depression Scale [ Time Frame: 14 weeks ]
  5. Short Form 36 [ Time Frame: 14 weeks ]
  6. Sheehan Disability Score [ Time Frame: 14 weeks ]
  7. Pain Visual Analogue Scale [ Time Frame: 14 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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): NCT00612170

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Sponsors and Collaborators
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Study Director: Pfizer CT.gov Call Center Pfizer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00612170    
Other Study ID Numbers: A6061043
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Keywords provided by Pfizer:
Phase 3, safety and efficacy study, [S,S[-Reboxetine, Fibromyalgia
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
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