Headache, Tension-Type
Conditions
Keywords
caffeine, paracetamol, tension headache
Brief summary
This study will compare a fast-absorbing paracetamol plus caffeine formula with placebo and an over-the-counter dose of paracetamol and ibuprofen to treat episodic tension headache.
Interventions
DRUGPlacebo
Placebo
DRUGExperimental paracetamol + caffeine formulation
experimental paracetamol + caffeine formulation
DRUGibuprofen marketed formulation
ibuprofen marketed formulation
Paracetamol marketed formulation
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of episodic tension-type headache consistent with all of the following: 1. number of days with the condition is historically greater than or equal to two per month 2. onset of condition was greater than or equal to 12 months from Visit 1 3. age of onset was \< 50 years 4. severity of headaches is historically at least moderate 5. duration of headaches is historically greater than or equal to four hours, if untreated 6. number of headache episodes was greater than or equal to 4 and less than or equal to 10 during each of the three months immediately prior to Visit 1 7. treatment of headache episodes with OTC analgesics has historically provided pain relief in less than or equal to 2 hours
Exclusion criteria
* Subject has chronic tension type headache, which is defined as headache on more than 15 days per month for 3 months. * If a migraine sufferer,subject averages more than one episode per month, is incapable of differentiating between tension-type headaches and migraine headaches, and/or requires regular or prophylactic use of migraine medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Perceptible Headache Relief | Baseline to 6 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Pain Relief (TOTPAR) | Baseline to 4 hours | 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. |
| Sum of Pain Intensity Difference (SPID) | Baseline to 4 hours | 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. |
| Sum of TOTPAR and SPID (SPRID) | Baseline to 4 hours | 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. |
| Headache Relief Scores | Baseline to 4 hours | 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. |
| Number of Participants With Complete Headache Relief | Baseline to 2 hours | 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. |
| Headache Severity | Baseline to 4 hours | 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. |
| Patients Global Assessment in Response to Treatment | Baseline to 8 weeks | 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. |
| Time to Rescue Medication | Baseline to 6 hours post dose | Time to rescue medication was evaluated. |
Countries
United States
Participant flow
Recruitment details
This was a multi-center study conducted at 7 centers.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Participants All randomized participants were evaluated for baseline measures. | 66 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Wash Out Period I | Other Reason | 3 |
| Washout Period II | Other Reason | 5 |
Baseline characteristics
| Characteristic | All Randomized Participants |
|---|---|
| Age, Continuous | 42.0 Years STANDARD_DEVIATION 12.46 |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 47 | 4 / 50 | 0 / 45 | 3 / 45 |
| serious Total, serious adverse events | 0 / 47 | 0 / 50 | 0 / 45 | 0 / 45 |
Outcome results
Primary
Time to First Perceptible Headache Relief
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.
Time frame: Baseline to 6 hours
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paracetamol/Caffeine | Time to First Perceptible Headache Relief | 30 minutes |
| Ibuprofen | Time to First Perceptible Headache Relief | 30 minutes |
| Paracetamol | Time to First Perceptible Headache Relief | 30 minutes |
| Placebo | Time to First Perceptible Headache Relief | 30 minutes |
Comparison: Null hypothesis considered no difference between the treatments in comparison.p-value: 0.28495% CI: [0.83, 1.9]Cox Proportional Hazard Model
Comparison: Null hypothesis considered no difference between the treatments in comparison.p-value: 0.200895% CI: [0.86, 2.01]Cox Proportional Hazard Model
Comparison: Null hypothesis considered no difference between the treatments in comparison.p-value: 0.455295% CI: [0.78, 1.74]Cox Proportional Hazard Model
p-value: 0.557995% CI: [0.75, 1.71]Cox Proportional Hazard Model
Comparison: Null hypothesis considered no difference between the treatments in comparison.p-value: 0.721495% CI: [0.72, 1.61]Cox Proportional Hazard Model
Comparison: Null hypothesis considered no difference between the treatments in comparison.p-value: 0.819295% CI: [0.62, 1.45]Cox Proportional Hazard Model
Secondary
Headache Relief Scores
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.
Time frame: Baseline to 4 hours
Population: ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paracetamol/Caffeine | Headache Relief Scores | 120 minutes | 3.50 Score on a scale | Standard Deviation 0.985 |
| Paracetamol/Caffeine | Headache Relief Scores | 240 minutes | 3.50 Score on a scale | Standard Deviation 1.012 |
| Paracetamol/Caffeine | Headache Relief Scores | 45 minutes | 1.87 Score on a scale | Standard Deviation 0.894 |
| Paracetamol/Caffeine | Headache Relief Scores | 30 minutes | 1.09 Score on a scale | Standard Deviation 1.095 |
| Paracetamol/Caffeine | Headache Relief Scores | 15 minutes | 0.15 Score on a scale | Standard Deviation 0.427 |
| Paracetamol/Caffeine | Headache Relief Scores | 90 minutes | 3.36 Score on a scale | Standard Deviation 0.903 |
| Paracetamol/Caffeine | Headache Relief Scores | 60 minutes | 2.79 Score on a scale | Standard Deviation 1.143 |
| Ibuprofen | Headache Relief Scores | 15 minutes | 0.08 Score on a scale | Standard Deviation 0.267 |
| Ibuprofen | Headache Relief Scores | 240 minutes | 3.75 Score on a scale | Standard Deviation 0.639 |
| Ibuprofen | Headache Relief Scores | 90 minutes | 3.16 Score on a scale | Standard Deviation 1.124 |
| Ibuprofen | Headache Relief Scores | 30 minutes | 0.84 Score on a scale | Standard Deviation 0.754 |
| Ibuprofen | Headache Relief Scores | 60 minutes | 2.49 Score on a scale | Standard Deviation 1.023 |
| Ibuprofen | Headache Relief Scores | 45 minutes | 1.61 Score on a scale | Standard Deviation 1.046 |
| Ibuprofen | Headache Relief Scores | 120 minutes | 3.46 Score on a scale | Standard Deviation 1.141 |
| Paracetamol | Headache Relief Scores | 240 minutes | 3.24 Score on a scale | Standard Deviation 1.179 |
| Paracetamol | Headache Relief Scores | 15 minutes | 0.29 Score on a scale | Standard Deviation 0.622 |
| Paracetamol | Headache Relief Scores | 30 minutes | 0.81 Score on a scale | Standard Deviation 0.877 |
| Paracetamol | Headache Relief Scores | 45 minutes | 1.46 Score on a scale | Standard Deviation 0.969 |
| Paracetamol | Headache Relief Scores | 60 minutes | 2.05 Score on a scale | Standard Deviation 1.161 |
| Paracetamol | Headache Relief Scores | 90 minutes | 2.95 Score on a scale | Standard Deviation 1.28 |
| Paracetamol | Headache Relief Scores | 120 minutes | 3.35 Score on a scale | Standard Deviation 1.169 |
| Placebo | Headache Relief Scores | 60 minutes | 2.21 Score on a scale | Standard Deviation 1.277 |
| Placebo | Headache Relief Scores | 45 minutes | 1.70 Score on a scale | Standard Deviation 1.222 |
| Placebo | Headache Relief Scores | 240 minutes | 3.55 Score on a scale | Standard Deviation 0.912 |
| Placebo | Headache Relief Scores | 120 minutes | 3.00 Score on a scale | Standard Deviation 1.414 |
| Placebo | Headache Relief Scores | 30 minutes | 0.87 Score on a scale | Standard Deviation 0.951 |
| Placebo | Headache Relief Scores | 15 minutes | 0.08 Score on a scale | Standard Deviation 0.273 |
| Placebo | Headache Relief Scores | 90 minutes | 2.95 Score on a scale | Standard Deviation 1.378 |
Secondary
Headache Severity
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.
Time frame: Baseline to 4 hours
Population: ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paracetamol/Caffeine | Headache Severity | 15 minutes | 0.35 Score on a scale | Standard Deviation 0.802 |
| Paracetamol/Caffeine | Headache Severity | 120 minutes | 2.94 Score on a scale | Standard Deviation 1.11 |
| Paracetamol/Caffeine | Headache Severity | 90 minutes | 2.97 Score on a scale | Standard Deviation 1.063 |
| Paracetamol/Caffeine | Headache Severity | 30 minutes | 1.03 Score on a scale | Standard Deviation 0.923 |
| Paracetamol/Caffeine | Headache Severity | 240 minutes | 2.82 Score on a scale | Standard Deviation 0.958 |
| Paracetamol/Caffeine | Headache Severity | 45 minutes | 1.77 Score on a scale | Standard Deviation 0.986 |
| Paracetamol/Caffeine | Headache Severity | 60 minutes | 2.50 Score on a scale | Standard Deviation 1.133 |
| Ibuprofen | Headache Severity | 120 minutes | 3.08 Score on a scale | Standard Deviation 1.1 |
| Ibuprofen | Headache Severity | 60 minutes | 2.36 Score on a scale | Standard Deviation 1.013 |
| Ibuprofen | Headache Severity | 45 minutes | 1.61 Score on a scale | Standard Deviation 0.919 |
| Ibuprofen | Headache Severity | 90 minutes | 2.76 Score on a scale | Standard Deviation 1.128 |
| Ibuprofen | Headache Severity | 240 minutes | 3.05 Score on a scale | Standard Deviation 0.887 |
| Ibuprofen | Headache Severity | 30 minutes | 0.77 Score on a scale | Standard Deviation 0.649 |
| Ibuprofen | Headache Severity | 15 minutes | 0.20 Score on a scale | Standard Deviation 0.464 |
| Paracetamol | Headache Severity | 60 minutes | 2.00 Score on a scale | Standard Deviation 1.065 |
| Paracetamol | Headache Severity | 15 minutes | 0.20 Score on a scale | Standard Deviation 0.406 |
| Paracetamol | Headache Severity | 30 minutes | 0.78 Score on a scale | Standard Deviation 0.584 |
| Paracetamol | Headache Severity | 45 minutes | 1.51 Score on a scale | Standard Deviation 0.823 |
| Paracetamol | Headache Severity | 90 minutes | 2.60 Score on a scale | Standard Deviation 1.172 |
| Paracetamol | Headache Severity | 120 minutes | 2.94 Score on a scale | Standard Deviation 1.197 |
| Paracetamol | Headache Severity | 240 minutes | 2.67 Score on a scale | Standard Deviation 0.856 |
| Placebo | Headache Severity | 45 minutes | 1.38 Score on a scale | Standard Deviation 0.924 |
| Placebo | Headache Severity | 240 minutes | 3.00 Score on a scale | Standard Deviation 0.926 |
| Placebo | Headache Severity | 120 minutes | 2.67 Score on a scale | Standard Deviation 1.238 |
| Placebo | Headache Severity | 30 minutes | 0.85 Score on a scale | Standard Deviation 0.779 |
| Placebo | Headache Severity | 15 minutes | 0.18 Score on a scale | Standard Deviation 0.692 |
| Placebo | Headache Severity | 90 minutes | 2.57 Score on a scale | Standard Deviation 1.192 |
| Placebo | Headache Severity | 60 minutes | 2.03 Score on a scale | Standard Deviation 1.102 |
Secondary
Number of Participants With Complete Headache Relief
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.
Time frame: Baseline to 2 hours
Population: ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paracetamol/Caffeine | Number of Participants With Complete Headache Relief | Headache resolved within 1 hour | 15 Participants |
| Paracetamol/Caffeine | Number of Participants With Complete Headache Relief | Headache resolved within 2 hour | 29 Participants |
| Ibuprofen | Number of Participants With Complete Headache Relief | Headache resolved within 2 hour | 30 Participants |
| Ibuprofen | Number of Participants With Complete Headache Relief | Headache resolved within 1 hour | 7 Participants |
| Paracetamol | Number of Participants With Complete Headache Relief | Headache resolved within 1 hour | 4 Participants |
| Paracetamol | Number of Participants With Complete Headache Relief | Headache resolved within 2 hour | 25 Participants |
| Placebo | Number of Participants With Complete Headache Relief | Headache resolved within 1 hour | 7 Participants |
| Placebo | Number of Participants With Complete Headache Relief | Headache resolved within 2 hour | 24 Participants |
Secondary
Patients Global Assessment in Response to Treatment
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.
Time frame: Baseline to 8 weeks
Population: ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paracetamol/Caffeine | Patients Global Assessment in Response to Treatment | Score 3 (Good) | 16 Score on a scale |
| Paracetamol/Caffeine | Patients Global Assessment in Response to Treatment | Score 1 (Poor) | 0 Score on a scale |
| Paracetamol/Caffeine | Patients Global Assessment in Response to Treatment | Score 4 (Very Good) | 12 Score on a scale |
| Paracetamol/Caffeine | Patients Global Assessment in Response to Treatment | Score 2 (Neutral) | 10 Score on a scale |
| Paracetamol/Caffeine | Patients Global Assessment in Response to Treatment | Score 0 (Very poor) | 1 Score on a scale |
| Ibuprofen | Patients Global Assessment in Response to Treatment | Score 2 (Neutral) | 5 Score on a scale |
| Ibuprofen | Patients Global Assessment in Response to Treatment | Score 3 (Good) | 19 Score on a scale |
| Ibuprofen | Patients Global Assessment in Response to Treatment | Score 4 (Very Good) | 18 Score on a scale |
| Ibuprofen | Patients Global Assessment in Response to Treatment | Score 1 (Poor) | 1 Score on a scale |
| Ibuprofen | Patients Global Assessment in Response to Treatment | Score 0 (Very poor) | 1 Score on a scale |
| Paracetamol | Patients Global Assessment in Response to Treatment | Score 2 (Neutral) | 6 Score on a scale |
| Paracetamol | Patients Global Assessment in Response to Treatment | Score 0 (Very poor) | 1 Score on a scale |
| Paracetamol | Patients Global Assessment in Response to Treatment | Score 1 (Poor) | 1 Score on a scale |
| Paracetamol | Patients Global Assessment in Response to Treatment | Score 3 (Good) | 15 Score on a scale |
| Paracetamol | Patients Global Assessment in Response to Treatment | Score 4 (Very Good) | 11 Score on a scale |
| Placebo | Patients Global Assessment in Response to Treatment | Score 3 (Good) | 17 Score on a scale |
| Placebo | Patients Global Assessment in Response to Treatment | Score 1 (Poor) | 4 Score on a scale |
| Placebo | Patients Global Assessment in Response to Treatment | Score 0 (Very poor) | 2 Score on a scale |
| Placebo | Patients Global Assessment in Response to Treatment | Score 2 (Neutral) | 3 Score on a scale |
| Placebo | Patients Global Assessment in Response to Treatment | Score 4 (Very Good) | 12 Score on a scale |
Secondary
Sum of Pain Intensity Difference (SPID)
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.
Time frame: Baseline to 4 hours
Population: ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paracetamol/Caffeine | Sum of Pain Intensity Difference (SPID) | SPID (0-60 minutes) | 1.49 Score on a scale | Standard Deviation 0.81 |
| Paracetamol/Caffeine | Sum of Pain Intensity Difference (SPID) | SPID (0-90 minutes) | 3.06 Score on a scale | Standard Deviation 1.25 |
| Paracetamol/Caffeine | Sum of Pain Intensity Difference (SPID) | SPID (0-120 minutes) | 4.42 Score on a scale | Standard Deviation 1.88 |
| Paracetamol/Caffeine | Sum of Pain Intensity Difference (SPID) | SPID (0-240 minutes) | 9.43 Score on a scale | Standard Deviation 3.62 |
| Ibuprofen | Sum of Pain Intensity Difference (SPID) | SPID (0-90 minutes) | 2.69 Score on a scale | Standard Deviation 1.13 |
| Ibuprofen | Sum of Pain Intensity Difference (SPID) | SPID (0-240 minutes) | 9.93 Score on a scale | Standard Deviation 3.28 |
| Ibuprofen | Sum of Pain Intensity Difference (SPID) | SPID (0-60 minutes) | 1.34 Score on a scale | Standard Deviation 0.64 |
| Ibuprofen | Sum of Pain Intensity Difference (SPID) | SPID (0-120 minutes) | 4.56 Score on a scale | Standard Deviation 1.73 |
| Paracetamol | Sum of Pain Intensity Difference (SPID) | SPID (0-120 minutes) | 4.32 Score on a scale | Standard Deviation 1.98 |
| Paracetamol | Sum of Pain Intensity Difference (SPID) | SPID (0-240 minutes) | 8.69 Score on a scale | Standard Deviation 2.77 |
| Paracetamol | Sum of Pain Intensity Difference (SPID) | SPID (0-60 minutes) | 1.15 Score on a scale | Standard Deviation 0.61 |
| Paracetamol | Sum of Pain Intensity Difference (SPID) | SPID (0-90 minutes) | 2.48 Score on a scale | Standard Deviation 1.18 |
| Placebo | Sum of Pain Intensity Difference (SPID) | SPID (0-240 minutes) | 9.51 Score on a scale | Standard Deviation 3.29 |
| Placebo | Sum of Pain Intensity Difference (SPID) | SPID (0-60 minutes) | 1.16 Score on a scale | Standard Deviation 0.72 |
| Placebo | Sum of Pain Intensity Difference (SPID) | SPID (0-90 minutes) | 2.42 Score on a scale | Standard Deviation 1.2 |
| Placebo | Sum of Pain Intensity Difference (SPID) | SPID (0-120 minutes) | 3.69 Score on a scale | Standard Deviation 1.7 |
Secondary
Sum of TOTPAR and SPID (SPRID)
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.
Time frame: Baseline to 4 hours
Population: ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paracetamol/Caffeine | Sum of TOTPAR and SPID (SPRID) | SPRID (0-120 minutes) | 9.50 Score on a scale | Standard Deviation 3.39 |
| Paracetamol/Caffeine | Sum of TOTPAR and SPID (SPRID) | SPRID (0-240 minutes) | 21.16 Score on a scale | Standard Deviation 6.18 |
| Paracetamol/Caffeine | Sum of TOTPAR and SPID (SPRID) | SPRID (0-90 minutes) | 6.43 Score on a scale | Standard Deviation 2.17 |
| Paracetamol/Caffeine | Sum of TOTPAR and SPID (SPRID) | SPRID (0-60 minutes) | 3.05 Score on a scale | Standard Deviation 1.43 |
| Ibuprofen | Sum of TOTPAR and SPID (SPRID) | SPRID (0-90 minutes) | 5.66 Score on a scale | Standard Deviation 2.13 |
| Ibuprofen | Sum of TOTPAR and SPID (SPRID) | SPRID (0-240 minutes) | 22.00 Score on a scale | Standard Deviation 5.46 |
| Ibuprofen | Sum of TOTPAR and SPID (SPRID) | SPRID (0-60 minutes) | 2.71 Score on a scale | Standard Deviation 1.19 |
| Ibuprofen | Sum of TOTPAR and SPID (SPRID) | SPRID (0-120 minutes) | 9.50 Score on a scale | Standard Deviation 3.08 |
| Paracetamol | Sum of TOTPAR and SPID (SPRID) | SPRID (0-90 minutes) | 5.14 Score on a scale | Standard Deviation 2.26 |
| Paracetamol | Sum of TOTPAR and SPID (SPRID) | SPRID (0-120 minutes) | 8.94 Score on a scale | Standard Deviation 3.65 |
| Paracetamol | Sum of TOTPAR and SPID (SPRID) | SPRID (0-240 minutes) | 19.35 Score on a scale | Standard Deviation 5.72 |
| Paracetamol | Sum of TOTPAR and SPID (SPRID) | SPRID (0-60 minutes) | 2.28 Score on a scale | Standard Deviation 1.17 |
| Placebo | Sum of TOTPAR and SPID (SPRID) | SPRID (0-60 minutes) | 2.42 Score on a scale | Standard Deviation 1.47 |
| Placebo | Sum of TOTPAR and SPID (SPRID) | SPRID (0-90 minutes) | 5.22 Score on a scale | Standard Deviation 2.43 |
| Placebo | Sum of TOTPAR and SPID (SPRID) | SPRID (0-240 minutes) | 20.70 Score on a scale | Standard Deviation 6.35 |
| Placebo | Sum of TOTPAR and SPID (SPRID) | SPRID (0-120 minutes) | 7.87 Score on a scale | Standard Deviation 3.34 |
Secondary
Time to Rescue Medication
Time to rescue medication was evaluated.
Time frame: Baseline to 6 hours post dose
Population: ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paracetamol/Caffeine | Time to Rescue Medication | 119.0 minutes |
| Ibuprofen | Time to Rescue Medication | 150.0 minutes |
| Paracetamol | Time to Rescue Medication | 129.5 minutes |
| Placebo | Time to Rescue Medication | 62.0 minutes |
Secondary
Total Pain Relief (TOTPAR)
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.
Time frame: Baseline to 4 hours
Population: ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paracetamol/Caffeine | Total Pain Relief (TOTPAR) | TOTPAR (0-60 minutes) | 1.57 Score on a scale | Standard Deviation 0.75 |
| Paracetamol/Caffeine | Total Pain Relief (TOTPAR) | TOTPAR (0-90 minutes) | 3.37 Score on a scale | Standard Deviation 1.08 |
| Paracetamol/Caffeine | Total Pain Relief (TOTPAR) | TOTPAR (0-120 minutes) | 5.08 Score on a scale | Standard Deviation 1.65 |
| Paracetamol/Caffeine | Total Pain Relief (TOTPAR) | TOTPAR (0-240 minutes) | 11.73 Score on a scale | Standard Deviation 3.22 |
| Ibuprofen | Total Pain Relief (TOTPAR) | TOTPAR (0-90 minutes) | 2.96 Score on a scale | Standard Deviation 1.18 |
| Ibuprofen | Total Pain Relief (TOTPAR) | TOTPAR (0-120 minutes) | 4.94 Score on a scale | Standard Deviation 1.63 |
| Ibuprofen | Total Pain Relief (TOTPAR) | TOTPAR (0-240 minutes) | 12.08 Score on a scale | Standard Deviation 2.48 |
| Ibuprofen | Total Pain Relief (TOTPAR) | TOTPAR (0-60 minutes) | 1.37 Score on a scale | Standard Deviation 0.64 |
| Paracetamol | Total Pain Relief (TOTPAR) | TOTPAR (0-120 minutes) | 4.62 Score on a scale | Standard Deviation 1.81 |
| Paracetamol | Total Pain Relief (TOTPAR) | TOTPAR (0-90 minutes) | 2.66 Score on a scale | Standard Deviation 1.2 |
| Paracetamol | Total Pain Relief (TOTPAR) | TOTPAR (0-240 minutes) | 10.65 Score on a scale | Standard Deviation 3.74 |
| Paracetamol | Total Pain Relief (TOTPAR) | TOTPAR (0-60 minutes) | 1.14 Score on a scale | Standard Deviation 0.68 |
| Placebo | Total Pain Relief (TOTPAR) | TOTPAR (0-240 minutes) | 11.19 Score on a scale | Standard Deviation 3.48 |
| Placebo | Total Pain Relief (TOTPAR) | TOTPAR (0-90 minutes) | 2.79 Score on a scale | Standard Deviation 1.4 |
| Placebo | Total Pain Relief (TOTPAR) | TOTPAR (0-60 minutes) | 1.26 Score on a scale | Standard Deviation 0.82 |
| Placebo | Total Pain Relief (TOTPAR) | TOTPAR (0-120 minutes) | 4.18 Score on a scale | Standard Deviation 1.97 |