Brain Imaging To Examine The Effect Of Naproxen In Hand Osteoarthritis Patients
NCT00830050
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Brain Imaging To Examine The Effect Of Naproxen In Hand Osteoarthritis Patients | |||
Official Title ICMJE | A Study To Determine The Ability Of FMRI To Detect And Quantify The Effect Of Naproxen On Osteoarthritis Of The Hand | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Early Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Basic Science | |||
Condition ICMJE | Osteoarthritis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 24 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | December 2010 | |||
Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00830050 | |||
Other Study ID Numbers ICMJE | A9001399 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | King's College London | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | March 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |