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Brain Imaging To Examine The Effect Of Naproxen In Hand Osteoarthritis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00830050
First Posted: January 27, 2009
Last Update Posted: March 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
King's College London
Information provided by:
Pfizer
January 26, 2009
January 27, 2009
March 14, 2011
July 2010
December 2010   (Final data collection date for primary outcome measure)
Changes in voxel-wise Blood Oxygen Level Dependent (BOLD) signal throughout the brain and changes in pre-defined brain regions of interest. [ Time Frame: 22 days ]
Same as current
Complete list of historical versions of study NCT00830050 on ClinicalTrials.gov Archive Site
  • Whole brain resting-state distribution of Cerebral Blood Flow [ Time Frame: 22 days ]
  • Psychometric measures of pain, namely Daily Pain Diaries and Present Pain Intensity [ Time Frame: 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) [ Time Frame: 22 days ]
Same as current
Not Provided
Not Provided
 
Brain Imaging To Examine The Effect Of Naproxen In Hand Osteoarthritis Patients
A Study To Determine The Ability Of FMRI To Detect And Quantify The Effect Of Naproxen On Osteoarthritis Of The Hand
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.
Not Provided
Interventional
Early Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Osteoarthritis
  • Drug: Naproxen
    500 mg BID 7 days
  • Drug: Placebo
    BID 7 days
  • Experimental: Arm 1
    Intervention: Drug: Naproxen
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2010
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
50 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00830050
A9001399
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
King's College London
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP