Trial Outcomes & Findings for Multiple Dose Dental Pain Study Of Ibuprofen Extended Release (NCT NCT01266161)
NCT ID: NCT01266161
Last Updated: 2018-08-15
Results Overview
SPRID is time-weighted sum of pain relief (PR) plus pain intensity (PI) difference (PID) (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0 equals \[=\] none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for PI: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement in pain intensity. SPRID 0-12 score ranged from -12 to 84; higher score indicated better efficacy.
COMPLETED
PHASE3
106 participants
Baseline to 12 hours
2018-08-15
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
Ibuprofen
Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
54
|
|
Overall Study
COMPLETED
|
48
|
53
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
Ibuprofen
Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
|---|---|---|
|
Overall Study
Ineligible
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Vomited within 4 hours of dosing
|
3
|
0
|
Baseline Characteristics
Multiple Dose Dental Pain Study Of Ibuprofen Extended Release
Baseline characteristics by cohort
| Measure |
Placebo
n=52 Participants
Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
Ibuprofen
n=54 Participants
Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.1 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
21.3 years
STANDARD_DEVIATION 3.6 • n=7 Participants
|
21.2 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Pain Severity
Moderate
|
37 participants
n=5 Participants
|
39 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Pain Severity
Severe
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Pain Intensity
|
73.8 millimeter
STANDARD_DEVIATION 12.25 • n=5 Participants
|
75.7 millimeter
STANDARD_DEVIATION 12.18 • n=7 Participants
|
74.8 millimeter
STANDARD_DEVIATION 12.20 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 hoursPopulation: Intent-to-treat (ITT) population: Randomized participants with at least moderate baseline pain (score 2 on the pain severity rating \[PSR\] scale) confirmed by a score of at least 50 millimeter (mm) on the 100-mm visual analog scale (VAS)-PSR, within approximately 5 hours after surgery, provided a baseline assessment, and received study medication.
SPRID is time-weighted sum of pain relief (PR) plus pain intensity (PI) difference (PID) (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0 equals \[=\] none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for PI: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement in pain intensity. SPRID 0-12 score ranged from -12 to 84; higher score indicated better efficacy.
Outcome measures
| Measure |
Placebo
n=52 Participants
Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
Ibuprofen
n=54 Participants
Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
|---|---|---|
|
Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores From 0 to 12 Hours After the First Dose (SPRID 0-12)
|
18.2 units on a scale
Standard Deviation 20.0
|
41.5 units on a scale
Standard Deviation 21.0
|
PRIMARY outcome
Timeframe: 8 to 12 hoursPopulation: ITT population
SPRID is time-weighted sum of PR plus PID (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPRID 8-12 score ranged from -4 to 28; higher score indicated better efficacy.
Outcome measures
| Measure |
Placebo
n=52 Participants
Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
Ibuprofen
n=54 Participants
Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
|---|---|---|
|
Sum of Pain Relief and Pain Intensity Difference Scores From 8-12 Hours After the First Dose
|
10.3 units on a scale
Standard Deviation 12.0
|
18.4 units on a scale
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: 0 to 12 hours, 8 to 12 hours, 12 to 24 hours, 20 to 24 hours, 0 to 24 hours, 24 to 36 hours, 32 to 36 hours, 36 to 48 hours, 44 to 48 hours, 24 to 48 hoursPopulation: ITT population
SPID is a derived endpoint from PID scores. For pain intensity, "How much pain do you have at this time?" answered on a 4-point categorical scale (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPID scores ranged as follows: 0 to 12 hour (-11.5 to 35.5), 8 to 12 hour (-6.0 to 18.0), 12 to 24 hour (-14.0 to 42.0), 20 to 24 hour (-8.0 to 24.0), 0 to 24 hour (-23.5 to 71.5), 24 to 36 hour (-16.0 to 48.0), 32 to 36 hour (-8.0 to 24.0), 36 to 48 hour (-16.0 to 48.0), 44 to 48 hour (-8.0 to 24.0), 24 to 48 hour (-28.0 to 84.0); higher positive values indicated improvement (decrease) in pain intensity.
Outcome measures
| Measure |
Placebo
n=52 Participants
Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
Ibuprofen
n=54 Participants
Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
|---|---|---|
|
Time-weighted Sum of Pain Intensity Difference (SPID) Scores
SPID 0-12
|
4.1 units on a scale
Standard Deviation 9.6
|
12.8 units on a scale
Standard Deviation 9.5
|
|
Time-weighted Sum of Pain Intensity Difference (SPID) Scores
SPID 8-12
|
2.5 units on a scale
Standard Deviation 5.4
|
5.5 units on a scale
Standard Deviation 5.2
|
|
Time-weighted Sum of Pain Intensity Difference (SPID) Scores
SPID 12-24
|
12.5 units on a scale
Standard Deviation 12.5
|
18.7 units on a scale
Standard Deviation 11.7
|
|
Time-weighted Sum of Pain Intensity Difference (SPID) Scores
SPID 20-24
|
8.8 units on a scale
Standard Deviation 7.5
|
10.7 units on a scale
Standard Deviation 7.3
|
|
Time-weighted Sum of Pain Intensity Difference (SPID) Scores
SPID 0-24
|
15.5 units on a scale
Standard Deviation 19.3
|
29.9 units on a scale
Standard Deviation 18.8
|
|
Time-weighted Sum of Pain Intensity Difference (SPID) Scores
SPID 24-36
|
16.2 units on a scale
Standard Deviation 15.2
|
21.6 units on a scale
Standard Deviation 13.9
|
|
Time-weighted Sum of Pain Intensity Difference (SPID) Scores
SPID 32-36
|
7.0 units on a scale
Standard Deviation 7.8
|
10.2 units on a scale
Standard Deviation 7.4
|
|
Time-weighted Sum of Pain Intensity Difference (SPID) Scores
SPID 36-48
|
17.4 units on a scale
Standard Deviation 14.2
|
23.0 units on a scale
Standard Deviation 13.8
|
|
Time-weighted Sum of Pain Intensity Difference (SPID) Scores
SPID 44-48
|
10.5 units on a scale
Standard Deviation 7.7
|
12.7 units on a scale
Standard Deviation 7.3
|
|
Time-weighted Sum of Pain Intensity Difference (SPID) Scores
SPID 24-48
|
30.5 units on a scale
Standard Deviation 25.2
|
40.7 units on a scale
Standard Deviation 23.9
|
SECONDARY outcome
Timeframe: Baseline to 12 hoursPopulation: ITT population. Here, "Number of participants analysed signifies those participants who were evaluable for this outcome measures".
During the first 12 hours of the study, participants not experiencing adequate relief after the 1-hour time point were allowed to take a single tablet (dose) of acetaminophen/hydrocodone hydrochloride (HCl) 500 mg/5 mg as a rescue medication (the only rescue medication allowed). The time at which rescue medication was taken was recorded.
Outcome measures
| Measure |
Placebo
n=40 Participants
Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
Ibuprofen
n=16 Participants
Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
|---|---|---|
|
Time to First Dose of Rescue Medication After First Dose of Study Drug
|
1.6 hours
Interval 1.4 to 2.2
|
NA hours
Median time was more than 12 hours. 95% CI was not estimable.
|
SECONDARY outcome
Timeframe: Baseline to 48 hoursPopulation: ITT population
Participants not experiencing adequate relief after the 1-hour time point during each dosing interval were allowed to take a single tablet (dose) of acetaminophen/hydrocodone HCl 500 mg/5 mg as a rescue medication (the only rescue medication allowed) during each interval.
Outcome measures
| Measure |
Placebo
n=52 Participants
Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
Ibuprofen
n=54 Participants
Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
|---|---|---|
|
Percentage of Participants Taking Rescue Medication
First dosing interval (0 to 12 hours)
|
76.9 percentage of participants
|
29.6 percentage of participants
|
|
Percentage of Participants Taking Rescue Medication
Second dosing interval (12 to 24 hours)
|
30.8 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants Taking Rescue Medication
Third dosing interval (24 to 36 hours)
|
32.7 percentage of participants
|
9.3 percentage of participants
|
|
Percentage of Participants Taking Rescue Medication
Fourth dosing interval (36 to 48 hours)
|
19.2 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants Taking Rescue Medication
Overall during the study (0 to 48 hours)
|
78.8 percentage of participants
|
31.5 percentage of participants
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hoursPopulation: ITT population
A 5-point categorical pain relief rating scale was used to rate pain relief in response to the question: "How much relief do you have from your starting pain?" Responses were scored as follows: 0=none, 1=a little, 2=some, 3=a lot, 4=complete. Higher score indicated more pain relief.
Outcome measures
| Measure |
Placebo
n=52 Participants
Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
Ibuprofen
n=54 Participants
Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
|---|---|---|
|
Pain Relief (PR) Scores
0.5 hours
|
0.4 units on a scale
Standard Deviation 0.7
|
1.3 units on a scale
Standard Deviation 1.1
|
|
Pain Relief (PR) Scores
1 hour
|
0.7 units on a scale
Standard Deviation 1.0
|
2.2 units on a scale
Standard Deviation 1.2
|
|
Pain Relief (PR) Scores
1.5 hours
|
0.6 units on a scale
Standard Deviation 1.0
|
2.6 units on a scale
Standard Deviation 1.3
|
|
Pain Relief (PR) Scores
2 hours
|
0.5 units on a scale
Standard Deviation 1.0
|
2.8 units on a scale
Standard Deviation 1.2
|
|
Pain Relief (PR) Scores
4 hours
|
0.7 units on a scale
Standard Deviation 1.3
|
2.9 units on a scale
Standard Deviation 1.3
|
|
Pain Relief (PR) Scores
6 hours
|
1.9 units on a scale
Standard Deviation 1.3
|
2.8 units on a scale
Standard Deviation 1.1
|
|
Pain Relief (PR) Scores
8 hours
|
1.4 units on a scale
Standard Deviation 1.3
|
2.4 units on a scale
Standard Deviation 1.3
|
|
Pain Relief (PR) Scores
10 hours
|
1.0 units on a scale
Standard Deviation 1.3
|
2.1 units on a scale
Standard Deviation 1.4
|
|
Pain Relief (PR) Scores
12 hours
|
1.5 units on a scale
Standard Deviation 1.5
|
1.9 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 hoursPopulation: ITT population
For pain intensity, "How much pain do you have at this time?" answered on a 4-point categorical scale. Responses were scored as follows: 0=none, 1=mild, 2=moderate, 3=severe. PID score=baseline pain intensity score minus score at each time point. PID scores ranged from -1 to 3. Higher positive PID scores indicated greater improvement (decrease in pain intensity).
Outcome measures
| Measure |
Placebo
n=52 Participants
Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
Ibuprofen
n=54 Participants
Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
|---|---|---|
|
Pain Intensity Difference (PID) Scores
0.5 hours
|
0.1 units on a scale
Standard Deviation 0.6
|
0.5 units on a scale
Standard Deviation 0.7
|
|
Pain Intensity Difference (PID) Scores
1 hour
|
0.1 units on a scale
Standard Deviation 0.8
|
1.0 units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference (PID) Scores
1.5 hours
|
0.0 units on a scale
Standard Deviation 0.9
|
1.2 units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference (PID) Scores
2 hours
|
-0.0 units on a scale
Standard Deviation 0.8
|
1.4 units on a scale
Standard Deviation 1.0
|
|
Pain Intensity Difference (PID) Scores
4 hours
|
0.1 units on a scale
Standard Deviation 1.0
|
1.4 units on a scale
Standard Deviation 1.0
|
|
Pain Intensity Difference (PID) Scores
6 hours
|
0.7 units on a scale
Standard Deviation 1.0
|
1.3 units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference (PID) Scores
8 hours
|
0.4 units on a scale
Standard Deviation 0.9
|
1.0 units on a scale
Standard Deviation 1.0
|
|
Pain Intensity Difference (PID) Scores
10 hours
|
0.3 units on a scale
Standard Deviation 0.9
|
0.9 units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference (PID) Scores
12 hours
|
0.5 units on a scale
Standard Deviation 1.2
|
0.8 units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference (PID) Scores
16 hours
|
0.7 units on a scale
Standard Deviation 0.9
|
1.6 units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference (PID) Scores
20 hours
|
1.0 units on a scale
Standard Deviation 1.0
|
1.4 units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference (PID) Scores
24 hours
|
1.2 units on a scale
Standard Deviation 1.0
|
1.2 units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference (PID) Scores
28 hours
|
1.1 units on a scale
Standard Deviation 1.1
|
1.6 units on a scale
Standard Deviation 1.0
|
|
Pain Intensity Difference (PID) Scores
32 hours
|
1.0 units on a scale
Standard Deviation 1.0
|
1.6 units on a scale
Standard Deviation 1.0
|
|
Pain Intensity Difference (PID) Scores
36 hours
|
0.8 units on a scale
Standard Deviation 1.0
|
1.0 units on a scale
Standard Deviation 1.0
|
|
Pain Intensity Difference (PID) Scores
40 hours
|
0.9 units on a scale
Standard Deviation 1.0
|
1.6 units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference (PID) Scores
44 hours
|
1.3 units on a scale
Standard Deviation 1.0
|
1.6 units on a scale
Standard Deviation 0.9
|
|
Pain Intensity Difference (PID) Scores
48 hours
|
1.4 units on a scale
Standard Deviation 1.0
|
1.6 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hoursPopulation: ITT population
PRID score=PR plus PID. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; PID score ranged from -1 to 3; higher positive PID value=improvement. PRID scores ranged from -1 to 7. Higher PRID scores indicated better pain relief and decrease in pain intensity.
Outcome measures
| Measure |
Placebo
n=52 Participants
Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
Ibuprofen
n=54 Participants
Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
|---|---|---|
|
Pain Relief Combined With Pain Intensity (PRID) Scores
0.5 hours
|
0.6 units on a scale
Standard Deviation 1.1
|
1.8 units on a scale
Standard Deviation 1.6
|
|
Pain Relief Combined With Pain Intensity (PRID) Scores
1 hour
|
0.8 units on a scale
Standard Deviation 1.7
|
3.2 units on a scale
Standard Deviation 2.0
|
|
Pain Relief Combined With Pain Intensity (PRID) Scores
1.5 hours
|
0.6 units on a scale
Standard Deviation 1.7
|
3.8 units on a scale
Standard Deviation 2.2
|
|
Pain Relief Combined With Pain Intensity (PRID) Scores
2 hours
|
0.5 units on a scale
Standard Deviation 1.7
|
4.1 units on a scale
Standard Deviation 2.1
|
|
Pain Relief Combined With Pain Intensity (PRID) Scores
4 hours
|
0.8 units on a scale
Standard Deviation 2.2
|
4.3 units on a scale
Standard Deviation 2.2
|
|
Pain Relief Combined With Pain Intensity (PRID) Scores
6 hours
|
2.5 units on a scale
Standard Deviation 2.2
|
4.0 units on a scale
Standard Deviation 1.9
|
|
Pain Relief Combined With Pain Intensity (PRID) Scores
8 hours
|
1.8 units on a scale
Standard Deviation 2.1
|
3.5 units on a scale
Standard Deviation 2.2
|
|
Pain Relief Combined With Pain Intensity (PRID) Scores
10 hours
|
1.3 units on a scale
Standard Deviation 2.0
|
3.0 units on a scale
Standard Deviation 2.2
|
|
Pain Relief Combined With Pain Intensity (PRID) Scores
12 hours
|
2.0 units on a scale
Standard Deviation 2.6
|
2.7 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 0-12 hours, 8-12 hoursPopulation: ITT population
TOTPAR is a derived endpoint from PR scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). TOTPAR 0-12 scores ranged from 0 (worst) to 48 (best). TOTPAR 8-12 scores ranged from 0 (worst) to 16 (best).
Outcome measures
| Measure |
Placebo
n=52 Participants
Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
Ibuprofen
n=54 Participants
Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
|---|---|---|
|
Time-weighted Sum of Pain Relief Scores (TOTPAR)
TOTPAR 0 to 12
|
14.1 units on a scale
Standard Deviation 11.2
|
28.7 units on a scale
Standard Deviation 12.3
|
|
Time-weighted Sum of Pain Relief Scores (TOTPAR)
TOTPAR 8 to 12
|
7.8 units on a scale
Standard Deviation 7.2
|
12.9 units on a scale
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: 0-12, 12-24, 24-36, 36-48, 0-48 hoursPopulation: ITT population
Outcome measures
| Measure |
Placebo
n=52 Participants
Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
Ibuprofen
n=54 Participants
Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
|---|---|---|
|
Number of Doses of Rescue Medication Used
Third dosing interval (24-36 hours)
|
0.5 doses
Standard Deviation 0.9
|
0.1 doses
Standard Deviation 0.5
|
|
Number of Doses of Rescue Medication Used
Fourth dosing interval (36-48 hours)
|
0.3 doses
Standard Deviation 0.7
|
0.1 doses
Standard Deviation 0.3
|
|
Number of Doses of Rescue Medication Used
First dosing interval (0-12 hours)
|
1.3 doses
Standard Deviation 1.0
|
0.4 doses
Standard Deviation 0.6
|
|
Number of Doses of Rescue Medication Used
Second dosing interval (12-24 hours)
|
0.4 doses
Standard Deviation 0.6
|
0.1 doses
Standard Deviation 0.2
|
|
Number of Doses of Rescue Medication Used
Overall during the study (0-48 hours)
|
2.5 doses
Standard Deviation 2.6
|
0.6 doses
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline to 12 hoursPopulation: ITT population. Here, "Number of participants analysed signifies those participants who were evaluable for this outcome measures".
The elapsed time from dosing until the participant indicated first perceptible pain relief by pressing the first stopwatch, provided the participant also indicated achieving meaningful relief by pressing the second stopwatch. Perceptible relief defined as when participant first began to feel any pain-relieving effect whatsoever of the drug. Did not necessarily mean the participant felt completely better, but when the participant first felt any difference in the pain he/she is currently feeling.
Outcome measures
| Measure |
Placebo
n=17 Participants
Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
Ibuprofen
n=48 Participants
Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
|---|---|---|
|
Time to Confirmed First Perceptible Relief
|
NA minutes
Median time to first perceptible relief was more than 720 minutes. 95% CI was not estimable.
|
25.0 minutes
Interval 20.1 to 28.5
|
SECONDARY outcome
Timeframe: Baseline to 12 hoursPopulation: ITT population. Here, "Number of participants analysed signifies those participants who were evaluable for this outcome measures".
Participants evaluated the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief, defined as relief from the pain that was considered meaningful to the participant.
Outcome measures
| Measure |
Placebo
n=17 Participants
Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
Ibuprofen
n=48 Participants
Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
|---|---|---|
|
Time to Meaningful Relief
|
NA minutes
Time to meaningful relief was more than 720 minutes. 95% CI not calculated.
|
54.2 minutes
Interval 46.5 to 79.6
|
SECONDARY outcome
Timeframe: 24 and 48 hoursPopulation: ITT population
Participants responded, on a 6-point categorical scale, to the following question: "How would you rate this medication as a pain-reliever?" Responses on this categorical scale ranged as follows: 0=very poor, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent.
Outcome measures
| Measure |
Placebo
n=52 Participants
Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
Ibuprofen
n=54 Participants
Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
|---|---|---|
|
Participant Global Evaluation Score
24 hours
|
1.2 units on a scale
Standard Deviation 1.4
|
3.5 units on a scale
Standard Deviation 1.2
|
|
Participant Global Evaluation Score
48 hours
|
1.7 units on a scale
Standard Deviation 1.5
|
3.7 units on a scale
Standard Deviation 1.0
|
Adverse Events
Placebo
Ibuprofen
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=52 participants at risk
Placebo 1 matching caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
Ibuprofen
n=54 participants at risk
Ibuprofen 600 milligrams (mg) extended release (ER) caplet administered orally up to 5 hours after surgery, thereafter every 12 hours up to 48 hours
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
1.9%
1/52
|
0.00%
0/54
|
|
Gastrointestinal disorders
Nausea
|
19.2%
10/52
|
1.9%
1/54
|
|
Gastrointestinal disorders
Vomiting
|
11.5%
6/52
|
0.00%
0/54
|
|
General disorders
Chills
|
1.9%
1/52
|
0.00%
0/54
|
|
General disorders
Feeling hot
|
3.8%
2/52
|
0.00%
0/54
|
|
General disorders
Flushing
|
1.9%
1/52
|
0.00%
0/54
|
|
Investigations
Blood pressure increased
|
1.9%
1/52
|
0.00%
0/54
|
|
Nervous system disorders
Dizziness
|
1.9%
1/52
|
0.00%
0/54
|
|
Nervous system disorders
Headache
|
17.3%
9/52
|
7.4%
4/54
|
|
Nervous system disorders
Skin burning sensation
|
0.00%
0/52
|
1.9%
1/54
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/52
|
1.9%
1/54
|
|
Psychiatric disorders
Anxiety
|
1.9%
1/52
|
0.00%
0/54
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/52
|
1.9%
1/54
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/52
|
3.7%
2/54
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
1/52
|
0.00%
0/54
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER