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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00752505
First received: September 12, 2008
Last updated: June 7, 2011
Last verified: June 2011
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Purpose
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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 ClinicalTrials.gov identifier: NCT00752505
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752505
Locations
| 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
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00752505 History of Changes |
| Other Study ID Numbers: | A6061061 |
| Study First Received: | September 12, 2008 |
| Last Updated: | June 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Fibromyalgia |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on September 26, 2016