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

This study has been terminated.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00607256
First received: January 23, 2008
Last updated: February 15, 2011
Last verified: February 2011
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Hematology/Biochemistry [ Time Frame: 68 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 68 weeks ] [ Designated as safety issue: No ]
  • Physical examination [ Time Frame: 68 weeks ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: 68 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Global Impression of Change [ Time Frame: 68 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607256

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00607256     History of Changes
Other Study ID Numbers: A6061046
Study First Received: January 23, 2008
Last Updated: February 15, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Reboxetine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014