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Long-term OL Study of [S,S]-RBX in Patients With Fibromyalgia

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00607256
First Posted: February 5, 2008
Last Update Posted: February 17, 2011
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.
Information provided by:
Pfizer
  Purpose
To evaluate the lon-term safety and tolerability of [S,S]-reboxetine in patients with fibromyalgia

Condition Intervention Phase
Fibromyalgia Drug: [S,S]-reboxetine Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 12-lead ECG [ Time Frame: 68 weeks ]
  • Hematology/Biochemistry [ Time Frame: 68 weeks ]
  • Adverse events [ Time Frame: 68 weeks ]
  • Physical examination [ Time Frame: 68 weeks ]
  • Vital signs [ Time Frame: 68 weeks ]

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

Estimated Enrollment: 500
Study Start Date: October 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Label Drug: [S,S]-reboxetine
S_S reboxetine dosed daily.

  Eligibility

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.


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

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
  Contacts and Locations
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): NCT00607256


  Show 80 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00607256     History of Changes
Other Study ID Numbers: A6061046
First Submitted: January 23, 2008
First Posted: February 5, 2008
Last Update Posted: February 17, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
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