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

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: NCT00752505
Recruitment Status : Completed
First Posted : September 15, 2008
Last Update Posted : June 21, 2011
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Esreboxetine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized Double-Blind Placebo-Controlled Crossover Study Assessing The Ability Of Esreboxetine (PNU-165442g) To Improve Cognitive Function In Fibromyalgia Patients.
Study Start Date : August 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A 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: B 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

Primary Outcome Measures :
  1. Computer based psychometric tests [ Time Frame: 11 week ]

Secondary Outcome Measures :
  1. A questionnaire to evaluate the subjects cognitive status [ Time Frame: Once at randomisatoin ]
  2. A questionnaire to assess the subjects mood [ Time Frame: 11 weeks ]
  3. A question to assess the subjects pain at visits [ Time Frame: 11 weeks ]
  4. A daily diary to assess the subjects pain [ Time Frame: 11 weeks ]
  5. A questionnaire to evaluate the impact the subject perceives fibromyalgia has on their cognitive ability [ Time Frame: Once at randomisation ]
  6. Two questionnaires to assess change in the subjects cognitive ability [ Time Frame: 11 weeks ]
  7. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00752505

United States, Florida
Pfizer Investigational Site
Destin, Florida, United States, 32541
Pfizer Investigational Site
Fort Walton Beach, Florida, United States, 32547
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109
Pfizer Investigational Site
Bingham Farms, Michigan, United States, 48025
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73103
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78756
Pfizer Investigational Site
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00752505     History of Changes
Other Study ID Numbers: A6061061
First Posted: September 15, 2008    Key Record Dates
Last Update Posted: June 21, 2011
Last Verified: June 2011

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases