Brain Imaging To Examine The Effect Of Naproxen In Hand O... | NCT00830050

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

NCT00830050

Sponsor

Pfizer

Status

Completed

Last Update Posted

Mar 14, 2011Estimated

Enrollment

24Actual

Phase

Early Phase 1

Conditions

Osteoarthritis

Interventions

Naproxen
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jan 26, 2009

First Submission Date that Met QC Criteria

Jan 26, 2009

First Posted Date

Jan 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2011

Last Update Posted Date

Mar 14, 2011Estimated

Name	Class
King's College London	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Naproxen
Arm 2	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Naproxen	Drug	500 mg BID 7 days	Arm 1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in voxel-wise Blood Oxygen Level Dependent (BOLD) signal throughout the brain and changes in pre-defined brain regions of interest.		22 days

Secondary Outcomes

Measure	Description	Time Frame
Whole brain resting-state distribution of Cerebral Blood Flow		22 days
Psychometric measures of pain, namely Daily Pain Diaries and Present Pain Intensity		22 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Denmark Hill	London	SE5 8AF	United Kingdom

References Module

Citations

Not provided

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D009280	Naphthaleneacetic Acids
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic