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

Early Phase 1CompletedNCT00830050

Pfizer24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Osteoarthritis

Interventions

NaproxenDRUG

500 mg BID 7 days

PlaceboDRUG

BID 7 days

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Denmark Hill, London, United Kingdom

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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