Trial Outcomes & Findings for 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) (NCT NCT01105936)
NCT ID: NCT01105936
Last Updated: 2017-06-21
Results Overview
BOLD response to painful pressure stimuli was evaluated using fMRI. Voxel-wise BOLD scores were reported on a Z-scale (Gaussian,mean=0,SD=1); range -3 (worst score, lowest connectivity) to +3 (best score, highest connectivity). The software derived scores compared the intensity reading in the region to a template, specifically the Montreal Neurological Institute (MNI) Echo-Planar Image (EPI) template. The template provides, for each region, expected (mean/median) intensity for that region, along with expected variation. The BOLD score on the Z-scale represents how far the actual measured intensity is from the expected in the template. A score of 0 would correspond to the mean/median, a score of 1.65 would represent the 90-percentile, -1.65 the 10-percentile, and so on, according to a standard normal distribution.
COMPLETED
PHASE4
31 participants
Baseline to 2-5 hours post last dose administration
2017-06-21
Participant Flow
Study was conducted at a single centre in Spain.
Out of 33 screened participants, 31 were randomized, while 2 participants were considered as screen failures
Participant milestones
| Measure |
Sequence 1
Participants took part in 3 study sessions. Session 1-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 2-no treatment was given. Session 3-participant took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
|
Sequence 2
Participants took part in 3 study sessions. Session 1-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 2-no treatment was given. Session 3-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
|
Sequence 3
Participants took part in 3 study sessions. Session 1-no treatment was given. Session 2-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 3-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered.A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
|
Sequence 4
Participants took part in 3 study sessions. Session 1-no treatment was given. Session 2-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 3-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
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Period 1
STARTED
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8
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8
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7
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8
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Period 1
COMPLETED
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8
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7
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7
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Period 1
NOT COMPLETED
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0
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0
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0
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1
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Wash-out Period 1
STARTED
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8
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8
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7
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Wash-out Period 1
COMPLETED
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8
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8
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Wash-out Period 1
NOT COMPLETED
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0
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0
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Period 2
STARTED
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8
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8
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Period 2
COMPLETED
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7
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Period 2
NOT COMPLETED
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1
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0
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0
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0
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Wash-out Period 2
STARTED
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7
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8
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7
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Wash-out Period 2
COMPLETED
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7
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8
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Wash-out Period 2
NOT COMPLETED
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0
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Period 3
STARTED
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7
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Period 3
COMPLETED
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6
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Period 3
NOT COMPLETED
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0
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2
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0
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Reasons for withdrawal
| Measure |
Sequence 1
Participants took part in 3 study sessions. Session 1-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 2-no treatment was given. Session 3-participant took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
|
Sequence 2
Participants took part in 3 study sessions. Session 1-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 2-no treatment was given. Session 3-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
|
Sequence 3
Participants took part in 3 study sessions. Session 1-no treatment was given. Session 2-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 3-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered.A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
|
Sequence 4
Participants took part in 3 study sessions. Session 1-no treatment was given. Session 2-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 3-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
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|---|---|---|---|---|
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Period 1
Adverse Event
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0
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0
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0
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1
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Period 2
Adverse Event
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1
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0
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0
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0
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Period 3
Protocol Violation
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0
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2
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0
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0
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Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Total Participants for Baseline Measurement
n=30 Participants
All randomized participants except one were evaluated for baseline measures. One participant had misallocated treatments that could not be determined. Therefore, this participant was excluded from all populations including safety.
|
|---|---|
|
Age, Customized
Years
|
68.5 Years
STANDARD_DEVIATION 7.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2-5 hours post last dose administrationPopulation: Intention-to-treat (ITT) population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.
BOLD response to painful pressure stimuli was evaluated using fMRI. Voxel-wise BOLD scores were reported on a Z-scale (Gaussian,mean=0,SD=1); range -3 (worst score, lowest connectivity) to +3 (best score, highest connectivity). The software derived scores compared the intensity reading in the region to a template, specifically the Montreal Neurological Institute (MNI) Echo-Planar Image (EPI) template. The template provides, for each region, expected (mean/median) intensity for that region, along with expected variation. The BOLD score on the Z-scale represents how far the actual measured intensity is from the expected in the template. A score of 0 would correspond to the mean/median, a score of 1.65 would represent the 90-percentile, -1.65 the 10-percentile, and so on, according to a standard normal distribution.
Outcome measures
| Measure |
Paracetamol 665 mg
n=20 Participants
Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
|
Placebo
n=23 Participants
Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
|
No Treatment
n=23 Participants
No treatment was given to participants.
|
|---|---|---|---|
|
Blood Oxygen Level-Dependent (BOLD) Response in the Tibio-femoral Joint of Knee Osteoarthritis (OA): [BOLD (T-f)]
|
NA Z-score
Standard Deviation NA
BOLD value had no detectable signal for Paracetamol 665 mg group.
|
NA Z-score
Standard Deviation NA
BOLD value had no detectable signal for Placebo group.
|
NA Z-score
Standard Deviation NA
BOLD value had no detectable signal for No Treatment group.
|
SECONDARY outcome
Timeframe: Baseline to 2-5 hours post last dose administrationPopulation: ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.
BOLD response to painful pressure stimuli was evaluated using fMRI. Voxel-wise BOLD scores were reported on a Z-scale (Gaussian,mean=0,SD=1); range -3 (worst score, lowest connectivity) to +3 (best score, highest connectivity). The software derived scores compared the intensity reading in the region to a template, specifically the Montreal Neurological Institute (MNI) Echo-Planar Image (EPI) template. The template provides, for each region, expected (mean/median) intensity for that region, along with expected variation. The BOLD score on the Z-scale represents how far the actual measured intensity is from the expected in the template. A score of 0 would correspond to the mean/median, a score of 1.65 would represent the 90-percentile, -1.65 the 10-percentile, and so on, according to a standard normal distribution
Outcome measures
| Measure |
Paracetamol 665 mg
n=20 Participants
Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
|
Placebo
n=23 Participants
Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
|
No Treatment
n=23 Participants
No treatment was given to participants.
|
|---|---|---|---|
|
BOLD Response in the Patello-femoral Joint of Knee Osteoarthritis: [BOLD (P-f)]
BOLD - Sensory Cortex (a)
|
0.16 Z-score
Standard Deviation 0.36
|
NA Z-score
Standard Deviation NA
BOLD - Sensory Cortex (a) value had no detectable signal for Placebo Group.
|
0.48 Z-score
Standard Deviation 0.48
|
|
BOLD Response in the Patello-femoral Joint of Knee Osteoarthritis: [BOLD (P-f)]
BOLD - Supramarginal Gyrus
|
0.46 Z-score
Standard Deviation 0.48
|
NA Z-score
Standard Deviation NA
BOLD - Supramarginal Gyrus value had no detectable signal for Placebo Group.
|
0.76 Z-score
Standard Deviation 0.49
|
|
BOLD Response in the Patello-femoral Joint of Knee Osteoarthritis: [BOLD (P-f)]
BOLD - Thalamus
|
0.48 Z-score
Standard Deviation 1.34
|
-0.68 Z-score
Standard Deviation 1.74
|
NA Z-score
Standard Deviation NA
BOLD - Thalamus value had no detectable signal for No treatment group.
|
|
BOLD Response in the Patello-femoral Joint of Knee Osteoarthritis: [BOLD (P-f)]
BOLD - Subgenu Prefrontal
|
NA Z-score
Standard Deviation NA
BOLD - Subgenu Prefrontal value had no detectable signal for Paracetamol 665 mg group.
|
-0.27 Z-score
Standard Deviation 0.41
|
0.19 Z-score
Standard Deviation 0.37
|
|
BOLD Response in the Patello-femoral Joint of Knee Osteoarthritis: [BOLD (P-f)]
BOLD - Frontal Cortex
|
NA Z-score
Standard Deviation NA
BOLD - Frontal Cortex value had no detectable signal for Paracetamol 665 mg group.
|
-0.04 Z-score
Standard Deviation 0.31
|
0.26 Z-score
Standard Deviation 0.42
|
|
BOLD Response in the Patello-femoral Joint of Knee Osteoarthritis: [BOLD (P-f)]
BOLD - Insula
|
NA Z-score
Standard Deviation NA
BOLD - Insula value had no detectable signal for Paracetamol 665 mg group.
|
0.12 Z-score
Standard Deviation 0.51
|
0.62 Z-score
Standard Deviation 0.62
|
|
BOLD Response in the Patello-femoral Joint of Knee Osteoarthritis: [BOLD (P-f)]
BOLD - Sensory Cortex (b)
|
NA Z-score
Standard Deviation NA
BOLD - Sensory Cortex (b) value had no detectable signal for Paracetamol 665 mg group.
|
-0.11 Z-score
Standard Deviation 0.60
|
0.44 Z-score
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Baseline and post-dose before stimulusPopulation: ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.
Subjective NRS response for each participant was calculated as difference of pre-treatment NRS pain assessment before stimulus and post-treatment NRS pain assessment before stimulus. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to "No Pain" and 10 corresponding to "Extreme Pain or Pain as bad as you can imagine".
Outcome measures
| Measure |
Paracetamol 665 mg
n=20 Participants
Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
|
Placebo
n=23 Participants
Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
|
No Treatment
n=23 Participants
No treatment was given to participants.
|
|---|---|---|---|
|
Subjective Numerical Rating Scale (NRS) Response for Treatment Effect on OA Knee Before Stimulation: [NRS (TRT)]
|
0.95 Score on a Scale
Standard Deviation 1.67
|
-0.52 Score on a Scale
Standard Deviation 1.53
|
0.48 Score on a Scale
Standard Deviation 1.83
|
SECONDARY outcome
Timeframe: Baseline and post-dose pre-scan after stimulusPopulation: ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.
Subjective NRS response was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment pre-scan pain assessment after stimulus on tibio-femoral joint. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to "No Pain" and 10 corresponding to "Extreme Pain or Pain as bad as you can imagine".
Outcome measures
| Measure |
Paracetamol 665 mg
n=20 Participants
Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
|
Placebo
n=23 Participants
Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
|
No Treatment
n=23 Participants
No treatment was given to participants.
|
|---|---|---|---|
|
Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation Prior the fMRI Scan: [NRS (T-f Pre-scan)]
|
0.55 Score on a Scale
Standard Deviation 0.89
|
0.17 Score on a Scale
Standard Deviation 1.07
|
0.00 Score on a Scale
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: Baseline and post-dose pre-scan after stimulusPopulation: ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.
Subjective NRS response was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment pre-scan pain assessment after stimulus on patello-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to "No Pain" and 10 corresponding to "Extreme Pain or Pain as bad as you can imagine".
Outcome measures
| Measure |
Paracetamol 665 mg
n=20 Participants
Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
|
Placebo
n=23 Participants
Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
|
No Treatment
n=23 Participants
No treatment was given to participants.
|
|---|---|---|---|
|
Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation Prior the fMRI Scan: [NRS (P-f Pre-scan)]
|
0.60 Score on a Scale
Standard Deviation 1.23
|
0.43 Score on a Scale
Standard Deviation 0.95
|
0.00 Score on a Scale
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: Baseline and post-dose post-scan after stimulusPopulation: ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.
Subjective NRS response for treatment effect on tibio-femoral stimulus after the fMRI scan was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment post-scan pain assessment after stimulus on tibio-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to "No Pain" and 10 corresponding to "Extreme Pain or Pain as bad as you can imagine".
Outcome measures
| Measure |
Paracetamol 665 mg
n=20 Participants
Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
|
Placebo
n=23 Participants
Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
|
No Treatment
n=23 Participants
No treatment was given to participants.
|
|---|---|---|---|
|
Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation After the fMRI Scan: [NRS (T-f Post-scan)]
|
0.15 Score on a Scale
Standard Deviation 1.18
|
0.09 Score on a Scale
Standard Deviation 1.38
|
-0.13 Score on a Scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Baseline and post-dose post-scan after stimulusPopulation: ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.
Subjective NRS response for each participant for treatment effect on tibio-femoral stimulus after the fMRI scan was calculated as difference of pre-treatment pain assessment after stimulus and post-treatment post-scan pain assessment after stimulus on patello-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to "No Pain" and 10 corresponding to "Extreme Pain or Pain as bad as you can imagine".
Outcome measures
| Measure |
Paracetamol 665 mg
n=20 Participants
Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
|
Placebo
n=23 Participants
Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
|
No Treatment
n=23 Participants
No treatment was given to participants.
|
|---|---|---|---|
|
Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation After the fMRI Scan: [NRS (P-f Post-scan)]
|
0.30 Score on a Scale
Standard Deviation 1.66
|
-0.48 Score on a Scale
Standard Deviation 1.62
|
-0.39 Score on a Scale
Standard Deviation 1.92
|
Adverse Events
Paracetamol 665 mg
Placebo
No Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Paracetamol 665 mg
n=29 participants at risk
Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
|
Placebo
n=28 participants at risk
Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
|
No Treatment
n=30 participants at risk
No treatment was given to participants.
|
|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
3.4%
1/29 • Number of events 1 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
3.6%
1/28 • Number of events 1 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
0.00%
0/30 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
|
Psychiatric disorders
Claustrophobia
|
0.00%
0/29 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
0.00%
0/28 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
3.3%
1/30 • Number of events 1 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
|
Gastrointestinal disorders
Dental caries
|
3.4%
1/29 • Number of events 1 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
0.00%
0/28 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
0.00%
0/30 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/29 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
3.6%
1/28 • Number of events 1 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
0.00%
0/30 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/29 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
0.00%
0/28 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
3.3%
1/30 • Number of events 1 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
3.4%
1/29 • Number of events 1 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
0.00%
0/28 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
0.00%
0/30 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
|
Nervous system disorders
Headache
|
0.00%
0/29 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
3.6%
1/28 • Number of events 1 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
0.00%
0/30 • Adverse Events were collected from the time of start of the investigational product, and until 5 days following last administration of the investigational product.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER