Clinical trial NCT01105936: 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)
Official title: A Randomised, Double-blind, Evaluation of the Effects of Paracetamol on the BOLD fMRI Response to Painful Stimuli in Subjects With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: osteoarthritis
pain
paracetamol
Blood-Oxygen-Level-Dependent functional magnetic resonance imaging
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-04-19
Enrollment: 31
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: The objective of this study is to investigate if functional magnetic response imaging (fMRI) can detect the effects of a known pain medicine at over-the-counter doses in people with osteoarthritis (OA) of the knee. The fMRI is a harmless and painless technique that is used in the current study to collect images of brain activity to see if is changed when feeling pain. In this study, BOLD response to mechanical stimulation via pressure stimuli applied to the tibio-femoral joint and patello-femoral in participants with knee OA following four treatment doses of any of three treatment will be compared.

Eligibility 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

Primary outcomes:
measure: 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:
measure: BOLD Response in the Patello-femoral Joint of Knee Osteoarthritis: [BOLD (P-f)]
timeFrame: Baseline to 2-5 hours post last dose administration
measure: Subjective Numerical Rating Scale (NRS) Response for Treatment Effect on OA Knee Before Stimulation: [NRS (TRT)]
timeFrame: Baseline and post-dose before stimulus
measure: 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
measure: 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
measure: 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
measure: 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
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Del Mar
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: