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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 12, 2008
Last updated: June 7, 2011
Last verified: June 2011
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 Intervention Phase
Fibromyalgia Drug: Esreboxetine Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Pfizer:

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

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

Enrollment: 89
Study Start Date: August 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00752505     History of Changes
Other Study ID Numbers: A6061061
Study First Received: September 12, 2008
Last Updated: June 7, 2011

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases processed this record on September 21, 2017