Last updated: 11/04/2018 04:21:16
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)
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomised, double-blind, evaluation of the effects of paracetamol on the BOLD fMRI response to painful stimuli in subjects with osteoarthritis
Trial description: Blood-Oxygen-Level-Dependent (BOLD) responses to painful mechanical stimulation of the OA knee following treatment with four consecutive doses (at 8 hour intervals) on giving sustained released paracetamol treatment or placebo will be compared. The fMRI and pain assessments will occur approximately 2-5 hours after taking the final dose.
Primary purpose:
Basic Science
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Blood Oxygen Level-Dependent (BOLD) response in the tibio-femoral joint of knee osteoarthritis (OA): [BOLD (t-f)]
Timeframe: Baseline to 2-5 hours post last dose administration
Secondary outcomes:
BOLD response in the patello-femoral joint of knee osteoarthritis: [BOLD (p-f)]
Timeframe: Baseline to 2-5 hours post last dose administration
Subjective numerical rating scale (NRS) response for treatment effect on OA knee before stimulation: [NRS (TRT)]
Timeframe: Baseline and post-dose before stimulus
Subjective NRS response for treatment effect on tibio-femoral stimulation prior the fMRI scan: [NRS (t-f Pre-scan)]
Timeframe: Baseline and post-dose pre-scan after stimulus
Subjective NRS response for treatment effect on patello-femoral stimulation prior the fMRI scan: [NRS (p-f Pre-scan)]
Timeframe: Baseline and post-dose pre-scan after stimulus
Subjective NRS response for treatment effect on tibio-femoral stimulation after the fMRI scan: [NRS (t-f Post-scan)]
Timeframe: Baseline and post-dose post-scan after stimulus
Subjective NRS response for treatment effect on patello-femoral stimulation after the fMRI scan: [NRS (p-f Post-scan)]
Timeframe: Baseline and post-dose post-scan after stimulus
Interventions:
Enrollment:
31
Primary completion date:
2011-17-08
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Osteoarthritis, Knee
Product
paracetamol
Collaborators
Not applicable
Study date(s)
September 2010 to August 2011
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
45+ years
Accepts healthy volunteers
No
- Diagnosis of osteoarthritis of at least one knee for 3 months
- Male or female at least 45 years of age
- If female, is pregnant, lactating, or breast feeding
- Has secondary cause of knee arthritis
Inclusion and exclusion criteria
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
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2011-17-08
Actual study completion date
2011-17-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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