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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01105936 |
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Date of registration:
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04/03/2010 |
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Primary sponsor: |
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Public title:
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Assess the Blood-Oxygen-Level-Dependent (BOLD) Signal Changes in the Brain by Paracetamol as Measured by Functional Magnetic Resonance Imaging (fMRI) in Subjects With Osteoarthritis (OA)
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Scientific title:
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A Randomised, Double-blind, Evaluation of the Effects of Paracetamol on the BOLD fMRI Response to Painful Stimuli in Subjects With Osteoarthritis |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01105936 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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Countries of recruitment
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Spain
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of osteoarthritis of at least one knee for 3 months
- Male or female at least 45 years of age
- Score a minimum of 4 out of 10 on the numerical pain rating and a maximum of 8 at
screening
Exclusion Criteria:
- If female, is pregnant, lactating, or breast feeding
- Has secondary cause of knee arthritis
- Lower extremity surgery in the last 6 months
- Prior injury in the last twelve months to the index knee
- Used any analgesics (NSAIDs, COX2 inhibitor, etc) within 5 half lives of study start
- Recently used oral or injected glucocorticoids
Age minimum:
45 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Osteoarthritis, Knee
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Intervention(s)
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Drug: Paracetamol
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Drug: Placebo
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Other: No treatment
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Primary Outcome(s)
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BOLD fMRI responses to painful mechanical stimulation of the osteoarthritic knee approximately 2-5 hours after final dose
[Time Frame: Approximately 2-5 hours after taking the final dose]
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Secondary Outcome(s)
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Pain assessment on a numerical rating scale measured approximately 2-5 hours after final dose
[Time Frame: Approximately 2-5 hours after taking the final dose]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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