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Maintenance of Efficacy.

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fibromyalgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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;

NCT00796601
Pfizer
Withdrawn
Maintenance of Efficacy.

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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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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Withdrawn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;
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Korea, Republic of,   Netherlands,   Norway
 
NCT00796601
A6061054
A6061054
Yes
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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