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

NCT ID: NCT00830050

Last Updated: 2011-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Naproxen

Intervention Type DRUG

500 mg BID 7 days

Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

BID 7 days

Interventions

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Naproxen

500 mg BID 7 days

Intervention Type DRUG

Placebo

BID 7 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Denmark Hill, London, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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Other Identifiers

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A9001399

Identifier Type: -

Identifier Source: org_study_id

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