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Open Label Extension 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. 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 : December 17, 2019
Information provided by (Responsible Party):

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 390 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Long-term, Open-label Extension Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia
Study Start Date : May 2008
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: 1 Drug: [S,S]-Reboxetine
Once a day, oral treatment, of 4, 6, 8 or 10 mg

Primary Outcome Measures :
  1. Vital Signs [ Time Frame: 66 weeks ]
  2. 12-Lead ECG [ Time Frame: 66 weeks ]
  3. Hematology & Biochemistry Laboratory Parameters [ Time Frame: 66 weeks ]
  4. Adverse Events [ Time Frame: 66 weeks ]

Secondary Outcome Measures :
  1. Short-Form 36 Health Survey [ Time Frame: 66 weeks ]
  2. Sheehan Disability Scale [ Time Frame: 66 weeks ]
  3. Pain Visual Analogue Scale [ Time Frame: 66 weeks ]
  4. Multidimensional Assessment of Fatigue [ Time Frame: 66 weeks ]
  5. Fibromyalgia Impact Questionaire [ Time Frame: 66 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)
  • 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

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 identifier (NCT number): NCT00754221

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Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer Identifier: NCT00754221    
Other Study ID Numbers: A6061053
First Posted: September 17, 2008    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Keywords provided by Pfizer:
Phase 3, safety 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