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Maintenance of Efficacy.

This study has been withdrawn prior to enrollment.
(This study has been cancelled as the esreboxetine development program is being discontinued. Safety and efficacy were not factors.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00796601
First received: November 20, 2008
Last updated: March 17, 2009
Last verified: March 2009
History of Changes

November 20, 2008
March 17, 2009
May 2009
May 2010   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline to 3 and 6 months in the FIQ-Total score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00796601 on ClinicalTrials.gov Archive Site
  • Pain (including other measures of daily pain and responder analyses); [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Function (including sub-scales of the FIQ, responder analyses of FIQ and SF-36); [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Global efficacy measures PGIC); [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Sleep (MOS); [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Work productivity; [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Depression (HADS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Safety (vital signs, ECG, laboratory, suicidal ideation) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Maintenance of Efficacy.
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.

The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Fibromyalgia
  • 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
  • Experimental: Esreboxetine
    Intervention: Drug: Esreboxetine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
650
November 2010
May 2010   (final data collection date for primary outcome measure)

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;
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00796601
A6061054, A6061054
Yes
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2009

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