Brain Imaging To Examine The Effect Of Naproxen In Hand Osteoarthritis Patients
Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: Naproxen (Drug); Placebo (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Centre for Neuroimaging Sciences, Phone: +44 (7919) 3047, Email: matthew.howard@iop.kcl.ac.uk
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.
Clinical Details
Official title: A Study To Determine The Ability Of FMRI To Detect And Quantify The Effect Of Naproxen On Osteoarthritis Of The Hand
Study design: Basic Science, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacodynamics Study
Primary outcome: Changes in voxel-wise Blood Oxygen Level Dependent (BOLD) signal throughout the brain and changes in pre-defined brain regions of interest.
Secondary outcome: Whole brain resting-state distribution of Cerebral Blood FlowPsychometric measures of pain, namely Daily Pain Diaries and Present Pain Intensity 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)
Eligibility
Minimum age: 50 Years.
Maximum age: 80 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Centre for Neuroimaging Sciences, Phone: +44 (7919) 3047, Email: matthew.howard@iop.kcl.ac.uk Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2009
Ending date: December 2009
Last updated: October 13, 2009
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