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Trial record 1 of 1 for:    NCT00796601
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Maintenance of Efficacy.

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: NCT00796601
Recruitment Status : Withdrawn
First Posted : November 24, 2008
Last Update Posted : November 29, 2018
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE November 20, 2008
First Posted Date  ICMJE November 24, 2008
Last Update Posted Date November 29, 2018
Actual Study Start Date  ICMJE May 1, 2009
Estimated Primary Completion Date May 1, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2008)
  • Change from baseline to 3 and 6 months in the mean daily pain rating score measured by the 11 point pain intensity Numerical Rating Scale (NRS). [ Time Frame: 6 months ]
  • Change from baseline to 3 and 6 months in the FIQ-Total score [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2008)
  • Pain (including other measures of daily pain and responder analyses); [ Time Frame: 6 months ]
  • Function (including sub-scales of the FIQ, responder analyses of FIQ and SF-36); [ Time Frame: 6 months ]
  • Global efficacy measures PGIC); [ Time Frame: 6 months ]
  • Sleep (MOS); [ Time Frame: 6 months ]
  • Work productivity; [ Time Frame: 6 months ]
  • Depression (HADS) [ Time Frame: 6 months ]
  • Safety (vital signs, ECG, laboratory, suicidal ideation) [ Time Frame: 6 months ]
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 Maintenance of Efficacy.
Official Title  ICMJE A 6-month, Double-blind, Placebo-controlled, Multi-center, Parallel Group, Maintenance Of Effect Study Of Esreboxetine (Pnu-165442g) Administered Once Daily (qd) In Patients With Fibromyalgia
Brief Summary The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Drug: Esreboxetine
    Film coated tablets (2, 6, 8, 10 mg esreboxetine), once daily for 6 months
  • Drug: Placebo
    Film coated tablets (0 mg esreboxetine), once daily for 6 months
Study Arms  ICMJE
  • Experimental: Esreboxetine
    Intervention: Drug: Esreboxetine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 27, 2018)
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2008)
Estimated Study Completion Date  ICMJE November 1, 2010
Estimated Primary Completion Date May 1, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must meet the American College of Rheumatology (ACR) criteria for fibromyalgia
  • Pain score greater than or equal to 4 on an 11-point NRS
  • FIQ-Total score greater than or equal to 45 points

Exclusion Criteria:

  • Other severe pain that may confound assessment or self evaluation of the pain associated with fibromyalgia
  • Any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), clinically significant active infection, or untreated endocrine disorder
  • Uncontrolled hypertension Pending Worker's Compensation; Current or recent diagnosis or episode of major depressive disorder, dysthymia and/or uncontrolled depression; Subjects to be at risk of suicide;
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 Not Provided
Removed Location Countries Korea, Republic of,   Netherlands,   Norway
Administrative Information
NCT Number  ICMJE NCT00796601
Other Study ID Numbers  ICMJE A6061054
2008-006760-10 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018

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