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

This study has been completed.
Sponsor:
Collaborator:
King's College London
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00830050
First received: January 26, 2009
Last updated: March 10, 2011
Last verified: March 2011
  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:


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:
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 April 14, 2014