Fibromyalgia Clinical Trial
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.
NCT number | NCT00752505 |
Other study ID # | A6061061 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | August 2008 |
Est. completion date | June 2009 |
Verified date | November 2018 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 89 |
Est. completion date | June 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Pfizer Investigational Site | Ann Arbor | Michigan |
United States | Pfizer Investigational Site | Austin | Texas |
United States | Pfizer Investigational Site | Bingham Farms | Michigan |
United States | Pfizer Investigational Site | Dallas | Texas |
United States | Pfizer Investigational Site | Destin | Florida |
United States | Pfizer Investigational Site | Fort Walton Beach | Florida |
United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Computer based psychometric tests | 11 week | ||
Secondary | A questionnaire to evaluate the subjects cognitive status | Once at randomisatoin | ||
Secondary | A questionnaire to assess the subjects mood | 11 weeks | ||
Secondary | A question to assess the subjects pain at visits | 11 weeks | ||
Secondary | A daily diary to assess the subjects pain | 11 weeks | ||
Secondary | A questionnaire to evaluate the impact the subject perceives fibromyalgia has on their cognitive ability | Once at randomisation | ||
Secondary | Two questionnaires to assess change in the subjects cognitive ability | 11 weeks | ||
Secondary | 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 |
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