Brain Imaging To Examine The Effect Of Naproxen In Hand Osteoarthritis Patients
This study has been completed.
Sponsor:
Pfizer
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
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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 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 October 18, 2012
