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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Early Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Naproxen
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteoarthritis focused on measuring fMRI functional magnetic resonance imaging Pain

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

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.

Secondary Outcome Measures

Whole brain resting-state distribution of Cerebral Blood Flow
Psychometric measures of pain, namely Daily Pain Diaries and Present Pain Intensity
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)

Full Information

First Posted
January 26, 2009
Last Updated
March 10, 2011
Sponsor
Pfizer
Collaborators
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT00830050
Brief Title
Brain Imaging To Examine The Effect Of Naproxen In Hand Osteoarthritis Patients
Official Title
A Study To Determine The Ability Of FMRI To Detect And Quantify The Effect Of Naproxen On Osteoarthritis Of The Hand
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer
Collaborators
King's College London

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
fMRI functional magnetic resonance imaging Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
500 mg BID 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
BID 7 days
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Whole brain resting-state distribution of Cerebral Blood Flow
Time Frame
22 days
Title
Psychometric measures of pain, namely Daily Pain Diaries and Present Pain Intensity
Time Frame
22 days
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Denmark Hill
State/Province
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9001399&StudyName=Brain%20Imaging%20To%20Examine%20The%20Effect%20Of%20Naproxen%20In%20Hand%20Osteoarthritis%20Patients
Description
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Brain Imaging To Examine The Effect Of Naproxen In Hand Osteoarthritis Patients

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