Trial Outcomes & Findings for Paracetamol With Caffeine to Treat Episodic Tension Type Headache (NCT NCT01755702)
NCT ID: NCT01755702
Last Updated: 2015-03-27
Results Overview
Time to first perceptible pain relief, calculated as time when partcipant selected 'a little' pain relief in the electronic pad minus the time of treatment. If this time was not available in the electronic pad then the earliest time corresponding to a pain relief score 1 or greater was recorded as time to 'a little' pain relief.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
66 participants
Primary outcome timeframe
Baseline to 6 hours
Results posted on
2015-03-27
Participant Flow
This was a multi-center study conducted at 7 centers.
66 participants were randomized. Each participant was expected to complete 1, 2, or 3 periods depending on number of headache episodes, for example participants experiencing 2 episodes would take the first 2 treatments, but would not get the 3rd treatment. Such participants would be considered as completer, not a withdrawal.
Participant milestones
| Measure |
Overall
In this cross-over study, participants were randomly-assigned to a blinded treatment sequence. Each participant was expected to complete 1, 2, or 3 periods depending on number of headache episodes.
The following treatments were administered during the study.
1. 1000/130mg paracetamol/caffeine (two 500/65mg caplets) plus placebo ibuprofen (two caplets) for a total of four caplets taken orally with approximately (approx.) 250 ml of water.
2. 1000mg paracetamol (two 500mg caplets) plus placebo paracetamol/caffeine (two caplets) taken orally with approx. 250 ml of water.
3. 400mg ibuprofen (two 200mg caplets) plus placebo paracetamol/caffeine (two caplets) for a total of four caplets taken orally with approx. 250 ml of water.
4. placebo paracetamol/caffeine (two caplets) plus placebo ibuprofen (two caplets) for a total of four caplets taken orally with approx. 250 ml of water.
|
|---|---|
|
Period I
STARTED
|
66
|
|
Period I
Received Paracetamol
|
16
|
|
Period I
Received Placebo
|
17
|
|
Period I
Received Ibuprofen
|
16
|
|
Period I
Received Paracetamol/Caffeine
|
17
|
|
Period I
COMPLETED
|
66
|
|
Period I
NOT COMPLETED
|
0
|
|
Wash Out Period I
STARTED
|
66
|
|
Wash Out Period I
COMPLETED
|
63
|
|
Wash Out Period I
NOT COMPLETED
|
3
|
|
Period II
STARTED
|
63
|
|
Period II
Received Ibuprofen
|
11
|
|
Period II
Received Placebo
|
15
|
|
Period II
Received Paracetamol/Caffeine
|
20
|
|
Period II
Received Paracetamol
|
17
|
|
Period II
COMPLETED
|
63
|
|
Period II
NOT COMPLETED
|
0
|
|
Washout Period II
STARTED
|
63
|
|
Washout Period II
COMPLETED
|
58
|
|
Washout Period II
NOT COMPLETED
|
5
|
|
Period III
STARTED
|
58
|
|
Period III
Received Paracetamol
|
17
|
|
Period III
Received Placebo
|
13
|
|
Period III
Received Paracetamol/Caffeine
|
10
|
|
Period III
Received Ibuprofen
|
18
|
|
Period III
COMPLETED
|
58
|
|
Period III
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Overall
In this cross-over study, participants were randomly-assigned to a blinded treatment sequence. Each participant was expected to complete 1, 2, or 3 periods depending on number of headache episodes.
The following treatments were administered during the study.
1. 1000/130mg paracetamol/caffeine (two 500/65mg caplets) plus placebo ibuprofen (two caplets) for a total of four caplets taken orally with approximately (approx.) 250 ml of water.
2. 1000mg paracetamol (two 500mg caplets) plus placebo paracetamol/caffeine (two caplets) taken orally with approx. 250 ml of water.
3. 400mg ibuprofen (two 200mg caplets) plus placebo paracetamol/caffeine (two caplets) for a total of four caplets taken orally with approx. 250 ml of water.
4. placebo paracetamol/caffeine (two caplets) plus placebo ibuprofen (two caplets) for a total of four caplets taken orally with approx. 250 ml of water.
|
|---|---|
|
Wash Out Period I
Other Reason
|
3
|
|
Washout Period II
Other Reason
|
5
|
Baseline Characteristics
Paracetamol With Caffeine to Treat Episodic Tension Type Headache
Baseline characteristics by cohort
| Measure |
All Randomized Participants
n=66 Participants
All randomized participants were evaluated for baseline measures.
|
|---|---|
|
Age, Continuous
|
42.0 Years
STANDARD_DEVIATION 12.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 hoursPopulation: Intention to treat (ITT) population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.
Time to first perceptible pain relief, calculated as time when partcipant selected 'a little' pain relief in the electronic pad minus the time of treatment. If this time was not available in the electronic pad then the earliest time corresponding to a pain relief score 1 or greater was recorded as time to 'a little' pain relief.
Outcome measures
| Measure |
Paracetamol/Caffeine
n=47 Participants
Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
|
Ibuprofen
n=50 Participants
Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Paracetamol
n=45 Participants
Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Placebo
n=45 Participants
Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
|
|---|---|---|---|---|
|
Time to First Perceptible Headache Relief
|
30 minutes
Interval 5.0 to 240.0
|
30 minutes
Interval 8.0 to 120.0
|
30 minutes
Interval 15.0 to 240.0
|
30 minutes
Interval 12.0 to 240.0
|
SECONDARY outcome
Timeframe: Baseline to 4 hoursPopulation: ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.
Pain relief scores were measured on a scale from 0-4: 0- No pain relief; 1- Perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief and 4- Complete relief.
Outcome measures
| Measure |
Paracetamol/Caffeine
n=47 Participants
Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
|
Ibuprofen
n=50 Participants
Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Paracetamol
n=45 Participants
Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Placebo
n=45 Participants
Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
|
|---|---|---|---|---|
|
Headache Relief Scores
60 minutes
|
2.79 Score on a scale
Standard Deviation 1.143
|
2.49 Score on a scale
Standard Deviation 1.023
|
2.05 Score on a scale
Standard Deviation 1.161
|
2.21 Score on a scale
Standard Deviation 1.277
|
|
Headache Relief Scores
15 minutes
|
0.15 Score on a scale
Standard Deviation 0.427
|
0.08 Score on a scale
Standard Deviation 0.267
|
0.29 Score on a scale
Standard Deviation 0.622
|
0.08 Score on a scale
Standard Deviation 0.273
|
|
Headache Relief Scores
30 minutes
|
1.09 Score on a scale
Standard Deviation 1.095
|
0.84 Score on a scale
Standard Deviation 0.754
|
0.81 Score on a scale
Standard Deviation 0.877
|
0.87 Score on a scale
Standard Deviation 0.951
|
|
Headache Relief Scores
45 minutes
|
1.87 Score on a scale
Standard Deviation 0.894
|
1.61 Score on a scale
Standard Deviation 1.046
|
1.46 Score on a scale
Standard Deviation 0.969
|
1.70 Score on a scale
Standard Deviation 1.222
|
|
Headache Relief Scores
90 minutes
|
3.36 Score on a scale
Standard Deviation 0.903
|
3.16 Score on a scale
Standard Deviation 1.124
|
2.95 Score on a scale
Standard Deviation 1.280
|
2.95 Score on a scale
Standard Deviation 1.378
|
|
Headache Relief Scores
120 minutes
|
3.50 Score on a scale
Standard Deviation 0.985
|
3.46 Score on a scale
Standard Deviation 1.141
|
3.35 Score on a scale
Standard Deviation 1.169
|
3.00 Score on a scale
Standard Deviation 1.414
|
|
Headache Relief Scores
240 minutes
|
3.50 Score on a scale
Standard Deviation 1.012
|
3.75 Score on a scale
Standard Deviation 0.639
|
3.24 Score on a scale
Standard Deviation 1.179
|
3.55 Score on a scale
Standard Deviation 0.912
|
SECONDARY outcome
Timeframe: Baseline to 4 hoursPopulation: ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.
TOTPAR was calculated as sum of the products of pain relief score at time interval at 0-60 minutes, 60-90 minutes, 90-120 minutes and 120-240 minutes. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score. It was calculated using the following formula. TOTPAR t = Σ(Rt x (time t - time t-1)), where Rt = pain relief score at time t; time t = time t in hours; time t-1 = time at previous time-point.
Outcome measures
| Measure |
Paracetamol/Caffeine
n=47 Participants
Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
|
Ibuprofen
n=50 Participants
Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Paracetamol
n=45 Participants
Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Placebo
n=45 Participants
Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
|
|---|---|---|---|---|
|
Total Pain Relief (TOTPAR)
TOTPAR (0-90 minutes)
|
3.37 Score on a scale
Standard Deviation 1.08
|
2.96 Score on a scale
Standard Deviation 1.18
|
2.66 Score on a scale
Standard Deviation 1.20
|
2.79 Score on a scale
Standard Deviation 1.40
|
|
Total Pain Relief (TOTPAR)
TOTPAR (0-120 minutes)
|
5.08 Score on a scale
Standard Deviation 1.65
|
4.94 Score on a scale
Standard Deviation 1.63
|
4.62 Score on a scale
Standard Deviation 1.81
|
4.18 Score on a scale
Standard Deviation 1.97
|
|
Total Pain Relief (TOTPAR)
TOTPAR (0-60 minutes)
|
1.57 Score on a scale
Standard Deviation 0.75
|
1.37 Score on a scale
Standard Deviation 0.64
|
1.14 Score on a scale
Standard Deviation 0.68
|
1.26 Score on a scale
Standard Deviation 0.82
|
|
Total Pain Relief (TOTPAR)
TOTPAR (0-240 minutes)
|
11.73 Score on a scale
Standard Deviation 3.22
|
12.08 Score on a scale
Standard Deviation 2.48
|
10.65 Score on a scale
Standard Deviation 3.74
|
11.19 Score on a scale
Standard Deviation 3.48
|
SECONDARY outcome
Timeframe: Baseline to 4 hoursPopulation: ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.
Sum of pain intensity difference (SPID) at 60, 90, 120 and 240 minutes - calculated as the sum of headache intensity differences between the baseline pain intensity score and pain intensity score at each timepoint. Pain intensity was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain. It was calculated using the following formula; SPID t = ΣPID x (time t - time t-1), where PID = PI (baseline) - PI t and PI = pain intensity.
Outcome measures
| Measure |
Paracetamol/Caffeine
n=47 Participants
Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
|
Ibuprofen
n=50 Participants
Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Paracetamol
n=45 Participants
Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Placebo
n=45 Participants
Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
|
|---|---|---|---|---|
|
Sum of Pain Intensity Difference (SPID)
SPID (0-90 minutes)
|
3.06 Score on a scale
Standard Deviation 1.25
|
2.69 Score on a scale
Standard Deviation 1.13
|
2.48 Score on a scale
Standard Deviation 1.18
|
2.42 Score on a scale
Standard Deviation 1.20
|
|
Sum of Pain Intensity Difference (SPID)
SPID (0-60 minutes)
|
1.49 Score on a scale
Standard Deviation 0.81
|
1.34 Score on a scale
Standard Deviation 0.64
|
1.15 Score on a scale
Standard Deviation 0.61
|
1.16 Score on a scale
Standard Deviation 0.72
|
|
Sum of Pain Intensity Difference (SPID)
SPID (0-120 minutes)
|
4.42 Score on a scale
Standard Deviation 1.88
|
4.56 Score on a scale
Standard Deviation 1.73
|
4.32 Score on a scale
Standard Deviation 1.98
|
3.69 Score on a scale
Standard Deviation 1.70
|
|
Sum of Pain Intensity Difference (SPID)
SPID (0-240 minutes)
|
9.43 Score on a scale
Standard Deviation 3.62
|
9.93 Score on a scale
Standard Deviation 3.28
|
8.69 Score on a scale
Standard Deviation 2.77
|
9.51 Score on a scale
Standard Deviation 3.29
|
SECONDARY outcome
Timeframe: Baseline to 4 hoursPopulation: ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.
Area under the time-response curve for change in headache intensity and headache relief (SPRID) at 60, 90, 120 and 240 minutes, was calculated as sum of TOTPAR and SPID: SPRIDt = TOTPARt + SPIDt TOTPAR was calculated as sum of the products of pain relief score. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score. SPID was calculated as the sum of headache intensity differences between baseline and at each time point. It was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.
Outcome measures
| Measure |
Paracetamol/Caffeine
n=47 Participants
Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
|
Ibuprofen
n=50 Participants
Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Paracetamol
n=45 Participants
Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Placebo
n=45 Participants
Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
|
|---|---|---|---|---|
|
Sum of TOTPAR and SPID (SPRID)
SPRID (0-60 minutes)
|
3.05 Score on a scale
Standard Deviation 1.43
|
2.71 Score on a scale
Standard Deviation 1.19
|
2.28 Score on a scale
Standard Deviation 1.17
|
2.42 Score on a scale
Standard Deviation 1.47
|
|
Sum of TOTPAR and SPID (SPRID)
SPRID (0-90 minutes)
|
6.43 Score on a scale
Standard Deviation 2.17
|
5.66 Score on a scale
Standard Deviation 2.13
|
5.14 Score on a scale
Standard Deviation 2.26
|
5.22 Score on a scale
Standard Deviation 2.43
|
|
Sum of TOTPAR and SPID (SPRID)
SPRID (0-120 minutes)
|
9.50 Score on a scale
Standard Deviation 3.39
|
9.50 Score on a scale
Standard Deviation 3.08
|
8.94 Score on a scale
Standard Deviation 3.65
|
7.87 Score on a scale
Standard Deviation 3.34
|
|
Sum of TOTPAR and SPID (SPRID)
SPRID (0-240 minutes)
|
21.16 Score on a scale
Standard Deviation 6.18
|
22.00 Score on a scale
Standard Deviation 5.46
|
19.35 Score on a scale
Standard Deviation 5.72
|
20.70 Score on a scale
Standard Deviation 6.35
|
SECONDARY outcome
Timeframe: Baseline to 6 hours post dosePopulation: ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.
Time to rescue medication was evaluated.
Outcome measures
| Measure |
Paracetamol/Caffeine
n=47 Participants
Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
|
Ibuprofen
n=50 Participants
Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Paracetamol
n=45 Participants
Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Placebo
n=45 Participants
Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
|
|---|---|---|---|---|
|
Time to Rescue Medication
|
119.0 minutes
Interval 119.0 to 119.0
|
150.0 minutes
Interval 126.0 to 211.0
|
129.5 minutes
Interval 129.0 to 130.0
|
62.0 minutes
Interval 62.0 to 149.0
|
SECONDARY outcome
Timeframe: Baseline to 2 hoursPopulation: ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.
Number of headaches resolved at 1 and 2 hours before any rescue medication was calculated as number of participants with complete pain relief and headache severity of 'no headache' over total number of participants. These calculations were based on one headache per treatment per subject.
Outcome measures
| Measure |
Paracetamol/Caffeine
n=47 Participants
Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
|
Ibuprofen
n=50 Participants
Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Paracetamol
n=45 Participants
Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Placebo
n=45 Participants
Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
|
|---|---|---|---|---|
|
Number of Participants With Complete Headache Relief
Headache resolved within 1 hour
|
15 Participants
|
7 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Complete Headache Relief
Headache resolved within 2 hour
|
29 Participants
|
30 Participants
|
25 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline to 4 hoursPopulation: ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.
Headache severity (scores) at 15, 30, 45, 60, 90, 120, and 240 minutes were calculated as change (difference) from baseline of pain intensity at each time point. Pain intensity was measured by numerical rating scale which is a horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.
Outcome measures
| Measure |
Paracetamol/Caffeine
n=47 Participants
Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
|
Ibuprofen
n=50 Participants
Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Paracetamol
n=45 Participants
Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Placebo
n=45 Participants
Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
|
|---|---|---|---|---|
|
Headache Severity
240 minutes
|
2.82 Score on a scale
Standard Deviation 0.958
|
3.05 Score on a scale
Standard Deviation 0.887
|
2.67 Score on a scale
Standard Deviation 0.856
|
3.00 Score on a scale
Standard Deviation 0.926
|
|
Headache Severity
15 minutes
|
0.35 Score on a scale
Standard Deviation 0.802
|
0.20 Score on a scale
Standard Deviation 0.464
|
0.20 Score on a scale
Standard Deviation 0.406
|
0.18 Score on a scale
Standard Deviation 0.692
|
|
Headache Severity
30 minutes
|
1.03 Score on a scale
Standard Deviation 0.923
|
0.77 Score on a scale
Standard Deviation 0.649
|
0.78 Score on a scale
Standard Deviation 0.584
|
0.85 Score on a scale
Standard Deviation 0.779
|
|
Headache Severity
45 minutes
|
1.77 Score on a scale
Standard Deviation 0.986
|
1.61 Score on a scale
Standard Deviation 0.919
|
1.51 Score on a scale
Standard Deviation 0.823
|
1.38 Score on a scale
Standard Deviation 0.924
|
|
Headache Severity
60 minutes
|
2.50 Score on a scale
Standard Deviation 1.133
|
2.36 Score on a scale
Standard Deviation 1.013
|
2.00 Score on a scale
Standard Deviation 1.065
|
2.03 Score on a scale
Standard Deviation 1.102
|
|
Headache Severity
90 minutes
|
2.97 Score on a scale
Standard Deviation 1.063
|
2.76 Score on a scale
Standard Deviation 1.128
|
2.60 Score on a scale
Standard Deviation 1.172
|
2.57 Score on a scale
Standard Deviation 1.192
|
|
Headache Severity
120 minutes
|
2.94 Score on a scale
Standard Deviation 1.110
|
3.08 Score on a scale
Standard Deviation 1.100
|
2.94 Score on a scale
Standard Deviation 1.197
|
2.67 Score on a scale
Standard Deviation 1.238
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksPopulation: ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.
Patients Global Assessment in Response to Treatment was assessed by a score in a scale from 0-4: 0- Poor; 1- Fair; 2- Good; 3- Very Good and 4- Excellent.
Outcome measures
| Measure |
Paracetamol/Caffeine
n=47 Participants
Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
|
Ibuprofen
n=50 Participants
Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Paracetamol
n=45 Participants
Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Placebo
n=45 Participants
Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
|
|---|---|---|---|---|
|
Patients Global Assessment in Response to Treatment
Score 0 (Very poor)
|
1 Score on a scale
|
1 Score on a scale
|
1 Score on a scale
|
2 Score on a scale
|
|
Patients Global Assessment in Response to Treatment
Score 1 (Poor)
|
0 Score on a scale
|
1 Score on a scale
|
1 Score on a scale
|
4 Score on a scale
|
|
Patients Global Assessment in Response to Treatment
Score 2 (Neutral)
|
10 Score on a scale
|
5 Score on a scale
|
6 Score on a scale
|
3 Score on a scale
|
|
Patients Global Assessment in Response to Treatment
Score 3 (Good)
|
16 Score on a scale
|
19 Score on a scale
|
15 Score on a scale
|
17 Score on a scale
|
|
Patients Global Assessment in Response to Treatment
Score 4 (Very Good)
|
12 Score on a scale
|
18 Score on a scale
|
11 Score on a scale
|
12 Score on a scale
|
Adverse Events
Paracetamol/Caffeine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Ibuprofen
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Paracetamol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Paracetamol/Caffeine
n=47 participants at risk
Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
|
Ibuprofen
n=50 participants at risk
Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Paracetamol
n=45 participants at risk
Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
|
Placebo
n=45 participants at risk
Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/47 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
2.0%
1/50 • Number of events 1 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/45 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/45 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/47 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/50 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/45 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
2.2%
1/45 • Number of events 1 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/47 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
2.0%
1/50 • Number of events 1 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/45 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/45 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/47 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
2.0%
1/50 • Number of events 1 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/45 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/45 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/47 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
2.0%
1/50 • Number of events 1 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/45 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/45 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/47 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/50 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/45 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
2.2%
1/45 • Number of events 1 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
|
Musculoskeletal and connective tissue disorders
Plantar Fascilitis
|
0.00%
0/47 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/50 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/45 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
2.2%
1/45 • Number of events 1 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.1%
1/47 • Number of events 1 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/50 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/45 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/45 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.1%
1/47 • Number of events 1 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/50 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/45 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
0.00%
0/45 • All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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