A Study To Assess Esreboxetine's Effect On Concentration, Memory, Decision Making And Problem Solving In Patients With Fibromyalgia.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00752505
First received: September 12, 2008
Last updated: June 7, 2011
Last verified: June 2011

September 12, 2008
June 7, 2011
August 2008
June 2009   (final data collection date for primary outcome measure)
Computer based psychometric tests [ Time Frame: 11 week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00752505 on ClinicalTrials.gov Archive Site
  • A questionnaire to evaluate the subjects cognitive status [ Time Frame: Once at randomisatoin ] [ Designated as safety issue: No ]
  • A questionnaire to assess the subjects mood [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • A question to assess the subjects pain at visits [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • A daily diary to assess the subjects pain [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • A questionnaire to evaluate the impact the subject perceives fibromyalgia has on their cognitive ability [ Time Frame: Once at randomisation ] [ Designated as safety issue: No ]
  • Two questionnaires to assess change in the subjects cognitive ability [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • Safety evaluations: medical history, physical and neurological exam, heart rate and blood pressure lying and standing, laboratory tests, electrical heart trace (ECG), adverse event collection, assessment of suicidal risk [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety evaluations: medical history, physical and neurological exam, heart rate and blood pressure lying and standing, laboratory tests, electrical heart trace (ECG), adverse event collection, assessment of suicidal risk [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Questionnaires to assess psychometric characteristics of fibromyalgia [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • A questionnaire to assess the subjects mood [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • A questionnaire to assess the subjects pain at visits [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • A daily diary to assess the subjects pain [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study To Assess Esreboxetine's Effect On Concentration, Memory, Decision Making And Problem Solving In Patients With Fibromyalgia.
A Phase 2 Randomized Double-Blind Placebo-Controlled Crossover Study Assessing The Ability Of Esreboxetine (PNU-165442g) To Improve Cognitive Function In Fibromyalgia Patients.

The study is designed to assess if esreboxetine can improve the cognitive function of patients with fibromyalgia. Cognitive function is defined as the ability to concentrate, remember things and make decisions or problem solve. The study is also designed to assess if there is a difference in cognitive function between fibromyalgia patients and matched control subjects.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fibromyalgia
Drug: Esreboxetine
Tablet once daily either placebo, 4mg or 8mg per day. Subjects will be on active treatment for 4 weeks out of a total of 11 weeks in a crossover dosing
  • Experimental: A
    Intervention: Drug: Esreboxetine
  • Experimental: B
    Intervention: Drug: Esreboxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who have a recognised diagnosis of fibromyalgia, with defined minimum pain criteria. Control subjects must not have a fibromyalgia diagnosis or symptoms and must match fibromyalgia subjects for age, length of education and gender

Exclusion Criteria:

  • Other confounding pain, cognitive disease or impairment, disease that could put the subject at risk or subjects who are on prohibited medications that cannot be washed out.
  • Any subjects with a diagnosis of certain psychiatric disorders in particular major depression or suicidal risk. Matched control subjects have similar exclusions.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00752505
A6061061
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2011

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