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Trial record 1 of 1 for:    NCT00607256
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Long-term OL Study of [S,S]-RBX in Patients With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00607256
Recruitment Status : Terminated
First Posted : February 5, 2008
Last Update Posted : February 17, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE January 23, 2008
First Posted Date  ICMJE February 5, 2008
Last Update Posted Date February 17, 2011
Study Start Date  ICMJE October 2007
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2008)
  • Vital signs [ Time Frame: 68 weeks ]
  • Physical examination [ Time Frame: 68 weeks ]
  • 12-lead ECG [ Time Frame: 68 weeks ]
  • Hematology/Biochemistry [ Time Frame: 68 weeks ]
  • Adverse events [ Time Frame: 68 weeks ]
Change History Complete list of historical versions of study NCT00607256 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2008)
Patient Global Impression of Change [ Time Frame: 68 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-term OL Study of [S,S]-RBX in Patients With Fibromyalgia
Official Title  ICMJE A Multi-center, Long-term, Open-label Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia
Brief Summary To evaluate the lon-term safety and tolerability of [S,S]-reboxetine in patients with fibromyalgia
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE Drug: [S,S]-reboxetine
S_S reboxetine dosed daily.
Study Arms  ICMJE Experimental: Open Label
Intervention: Drug: [S,S]-reboxetine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: January 23, 2008)
500
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Czech Republic,   France,   Germany,   Korea, Republic of,   Netherlands,   South Africa,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00607256
Other Study ID Numbers  ICMJE A6061046
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP