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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esreboxetine | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Computer based psychometric tests | 11 week |
| Measure | Description | Time Frame |
|---|---|---|
| A questionnaire to evaluate the subjects cognitive status | Once at randomisatoin | |
| A questionnaire to assess the subjects mood | 11 weeks | |
| A question to assess the subjects pain at visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Destin | Florida | 32541 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Esreboxetine | Drug | 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 |
|
| 11 weeks |
| A daily diary to assess the subjects pain | 11 weeks |
| A questionnaire to evaluate the impact the subject perceives fibromyalgia has on their cognitive ability | Once at randomisation |
| Two questionnaires to assess change in the subjects cognitive ability | 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 | 12 weeks |
| Fort Walton Beach |
| Florida |
| 32547 |
| United States |
| Pfizer Investigational Site | Ann Arbor | Michigan | 48109 | United States |
| Pfizer Investigational Site | Bingham Farms | Michigan | 48025 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| Pfizer Investigational Site | Austin | Texas | 78756 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75231 | United States |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C541385 | esreboxetine |
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