You are here

Maintenance of Efficacy.

Last updated on November 14, 2019

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Withdrawn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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
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 SummaryThe hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.
Detailed DescriptionNot 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 27, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2008)
650
Estimated Study Completion Date  ICMJE November 1, 2010
Estimated Primary Completion DateMay 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 CountriesKorea, Republic of,   Netherlands,   Norway
 
Administrative Information
NCT Number  ICMJE NCT00796601
Other Study ID Numbers  ICMJE A6061054
A6061054
2008-006760-10 ( EudraCT Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot 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: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2018

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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now