Phase 4
N=31
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)
Osteoarthritis, Knee
Bottom Line
View on ClinicalTrials.gov: NCT01105936 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Blood Oxygen Level-Dependent (BOLD) Response in the Tibio-femoral Joint of Knee Osteoarthritis (OA): [BOLD (T-f)] — NA; NA; NA Z-score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Paracetamol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Oxygen Level-Dependent (BOLD) Response in the Tibio-femoral Joint of Knee Osteoarthritis (OA): [BOLD (T-f)] |
NA; NA; NA | — |
| SECONDARY BOLD Response in the Patello-femoral Joint of Knee Osteoarthritis: [BOLD (P-f)] |
0.16; NA; 0.48; 0.46; NA; 0.76 | — |
| SECONDARY Subjective Numerical Rating Scale (NRS) Response for Treatment Effect on OA Knee Before Stimulation: [NRS (TRT)] |
0.95; -0.52; 0.48 | — |
| SECONDARY Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation Prior the fMRI Scan: [NRS (T-f Pre-scan)] |
0.55; 0.17; 0.00 | — |
| SECONDARY Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation Prior the fMRI Scan: [NRS (P-f Pre-scan)] |
0.60; 0.43; 0.00 | — |
| SECONDARY Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation After the fMRI Scan: [NRS (T-f Post-scan)] |
0.15; 0.09; -0.13 | — |
| SECONDARY Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation After the fMRI Scan: [NRS (P-f Post-scan)] |
0.30; -0.48; -0.39 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01105936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.