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

This study is not yet open for participant recruitment.

Verified by Pfizer, January 2010

First Received: January 26, 2009 Last Updated: January 25, 2010 History of Changes

Sponsor:	Pfizer
Collaborators:	King's College London St Thomas' Hospital, London
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00830050

Purpose

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	Intervention	Phase
Osteoarthritis	Drug: Naproxen Drug: Placebo	Phase 0

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacodynamics Study
Official Title:	A Study To Determine The Ability Of FMRI To Detect And Quantify The Effect Of Naproxen On Osteoarthritis Of The Hand

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Whole brain resting-state distribution of Cerebral Blood Flow [ Time Frame: 22 days ] [ Designated as safety issue: No ]
Psychometric measures of pain, namely Daily Pain Diaries and Present Pain Intensity [ Time Frame: 22 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	February 2010
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Naproxen 500 mg BID 7 days
Arm 2: Placebo Comparator	Drug: Placebo BID 7 days

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830050

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

King's College London

St Thomas' Hospital, London

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A9001399
Study First Received:	January 26, 2009
Last Updated:	January 25, 2010
ClinicalTrials.gov Identifier:	NCT00830050 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Pfizer:

fMRI functional magnetic resonance imaging Pain

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Naproxen
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Joint Diseases
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Rheumatic Diseases
Gout Suppressants
Pharmacologic Actions

Musculoskeletal Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Arthritis
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010