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

Pfizer

Status and phase: Completed; Early Phase 1

Conditions: Osteoarthritis

Treatments: Drug: Naproxen; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00830050

A9001399

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Female

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Naproxen

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo