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

NCT00830050

Last updated date
Study Location
Pfizer Investigational Site
Denmark Hill, London, SE5 8AF, United Kingdom
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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
  • Drug: Naproxen
    500 mg BID 7 days
  • Drug: Placebo
    BID 7 days
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: Naproxen
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
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
 (submitted: January 26, 2009)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
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
Study Director:Pfizer CT.gov Call CenterPfizer
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