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

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. Identifier: NCT00830050
Recruitment Status : Completed
First Posted : January 27, 2009
Last Update Posted : March 14, 2011
King's College London
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Naproxen Drug: Placebo Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Study To Determine The Ability Of FMRI To Detect And Quantify The Effect Of Naproxen On Osteoarthritis Of The Hand
Study Start Date : July 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Drug: Naproxen
500 mg BID 7 days
Placebo Comparator: Arm 2 Drug: Placebo
BID 7 days

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Whole brain resting-state distribution of Cerebral Blood Flow [ Time Frame: 22 days ]
  2. Psychometric measures of pain, namely Daily Pain Diaries and Present Pain Intensity [ Time Frame: 22 days ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00830050

United Kingdom
Pfizer Investigational Site
Denmark Hill, London, United Kingdom, SE5 8AF
Sponsors and Collaborators
King's College London
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00830050     History of Changes
Other Study ID Numbers: A9001399
First Posted: January 27, 2009    Key Record Dates
Last Update Posted: March 14, 2011
Last Verified: March 2011

Keywords provided by Pfizer:
fMRI functional magnetic resonance imaging Pain

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action