Brain Imaging To Examine The Effect Of Naproxen In Hand Osteoarthritis Patients - Full Text View

Sponsor:	Pfizer
Collaborator:	King's College 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:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
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 ]

Enrollment:	24
Study Start Date:	July 2010
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

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

Locations

United Kingdom
Pfizer Investigational Site
Denmark Hill, London, United Kingdom, SE5 8AF

Sponsors and Collaborators

Pfizer

King's College 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:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00830050 History of Changes
Other Study ID Numbers:	A9001399
Study First Received:	January 26, 2009
Last Updated:	March 10, 2011
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Pfizer:

fMRI functional magnetic resonance imaging Pain

Additional relevant MeSH terms:

Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 24, 2012