NCT00752505CompletedPhase 2
A Phase 2 Randomized Double-Blind Placebo-Controlled Crossover Study Assessing The Ability Of Esreboxetine (PNU-165442g) To Improve Cognitive Function In Fibromyalgia Patients.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- Computer based psychometric tests
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
A
Experimental
Intervention: Esreboxetine (Drug)
B
Experimental
Intervention: Esreboxetine (Drug)
Outcomes
Primary Outcomes
Computer based psychometric tests
Time Frame: 11 week
Secondary Outcomes
- A questionnaire to assess the subjects mood(11 weeks)
- A questionnaire to evaluate the subjects cognitive status(Once at randomisatoin)
- A question to assess the subjects pain at visits(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)
- A daily diary to assess the subjects pain(11 weeks)
- Two questionnaires to assess change in the subjects cognitive ability(11 weeks)
- A questionnaire to evaluate the impact the subject perceives fibromyalgia has on their cognitive ability(Once at randomisation)
Investigators
Study Sites (1)
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