Long-term OL Study of [S,S]-RBX 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: NCT00607256
Recruitment Status : Terminated
First Posted : February 5, 2008
Last Update Posted : February 17, 2011
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Brief Summary:
To evaluate the lon-term safety and tolerability of [S,S]-reboxetine in patients with fibromyalgia

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 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 Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia
Study Start Date : October 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: Open Label Drug: [S,S]-reboxetine
S_S reboxetine dosed daily.

Primary Outcome Measures :
  1. 12-lead ECG [ Time Frame: 68 weeks ]
  2. Hematology/Biochemistry [ Time Frame: 68 weeks ]
  3. Adverse events [ Time Frame: 68 weeks ]
  4. Physical examination [ Time Frame: 68 weeks ]
  5. Vital signs [ Time Frame: 68 weeks ]

Secondary Outcome Measures :
  1. Patient Global Impression of Change [ Time Frame: 68 weeks ]

Information from the National Library of Medicine

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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:

  • Diagnosis of patients meeting the ACR criteria for fibromyalgia (i.e. 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 (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia

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): NCT00607256

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc Identifier: NCT00607256     History of Changes
Other Study ID Numbers: A6061046
First Posted: February 5, 2008    Key Record Dates
Last Update Posted: February 17, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
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