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Completed

NCT Number: NCT00830050

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

50 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Pfizer Investigational Site

Denmark Hill, London, SE5 8AF, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naproxen

Drug

500 mg BID 7 days

Placebo

Drug

BID 7 days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • King's College London

Registry information

Official study title

A Study To Determine The Ability Of FMRI To Detect And Quantify The Effect Of Naproxen On Osteoarthritis Of The Hand

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 27, 2009
Registry last updated
Mar 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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