A Study To Assess Esreboxetine's Effect On Concentration, Memory, Decision Making And Problem Solving In Patients With Fibromyalgia.
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ClinicalTrials.gov Identifier: NCT00752505 |
Recruitment Status
:
Completed
First Posted
: September 15, 2008
Last Update Posted
: June 21, 2011
|
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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 |

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
|
- Computer based psychometric tests [ Time Frame: 11 week ]
- 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 ]

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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.

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 ClinicalTrials.gov 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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov 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:
Fibromyalgia |
Additional relevant MeSH terms:
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |