Brain Imaging To Examine The Effect Of Naproxen In Hand Osteoarthritis Patients
- Registration Number
- NCT00830050
- Lead Sponsor
- Pfizer
- Brief Summary
The study hypothesis is that the relief of pain in patients with osteoarthritis in the hand can be detected by a form of brain scanning that detects which parts of the brain are activated when pain is felt.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 24
Inclusion Criteria
- Right-handed, post-menopausal female, any race, 50-80 years
- Clinical diagnosis of osteoarthritis of the hand
- Estimated pain in this joint of at least 5 on a scale of 0 to 10
Exclusion Criteria
- Any patient who smokes more than 5 cigarettes per day
- Patients receiving some anti-depressant drugs unless the dose is stable
- Patients unable to be admitted or lie still in an MRI scanner
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 2 Placebo - Arm 1 Naproxen -
- Primary Outcome Measures
Name Time Method Changes in voxel-wise Blood Oxygen Level Dependent (BOLD) signal throughout the brain and changes in pre-defined brain regions of interest. 22 days
- Secondary Outcome Measures
Name Time Method Whole brain resting-state distribution of Cerebral Blood Flow 22 days Psychometric measures of pain, namely Daily Pain Diaries and Present Pain Intensity 22 days Pain induced by a grip task measured with a Visual Analogue Scale (VAS), the Short-Form McGill Pain Questionnaire and patient-rated wrist/hand evaluation (PRWHE) 22 days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧Denmark Hill, London, United Kingdom