Trial Outcomes & Findings for A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain (NCT NCT02476422)
NCT ID: NCT02476422
Last Updated: 2016-10-17
Results Overview
VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their current level of pain intensity on the 100 mm VASPI, labeled "no pain" (0 mm) as the left anchor and "worst possible pain" (100 mm) as the right anchor. A positive change represents a reduction in pain.
COMPLETED
PHASE3
328 participants
60 minutes postdose
2016-10-17
Participant Flow
Participant milestones
| Measure |
Dilcofenac Potassium + Placebo to Ibuprofen
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
|
Ibuprofen + Placebo to Diclofenac Potassium
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
162
|
|
Overall Study
COMPLETED
|
166
|
161
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Dilcofenac Potassium + Placebo to Ibuprofen
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
|
Ibuprofen + Placebo to Diclofenac Potassium
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
|
|---|---|---|
|
Overall Study
Subject/guardian decision
|
0
|
1
|
Baseline Characteristics
A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain
Baseline characteristics by cohort
| Measure |
Dilcofenac Potassium + Placebo to Ibuprofen
n=166 Participants
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
|
Ibuprofen + Placebo to Diclofenac Potassium
n=162 Participants
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
|
Total
n=328 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
24.9 Years
STANDARD_DEVIATION 5.21 • n=5 Participants
|
24.7 Years
STANDARD_DEVIATION 6.11 • n=7 Participants
|
24.8 Years
STANDARD_DEVIATION 5.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 minutes postdosePopulation: The efficacy analyses were performed on the full analysis set (FAS) which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.
VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their current level of pain intensity on the 100 mm VASPI, labeled "no pain" (0 mm) as the left anchor and "worst possible pain" (100 mm) as the right anchor. A positive change represents a reduction in pain.
Outcome measures
| Measure |
Dilcofenac Potassium + Placebo to Ibuprofen
n=166 Participants
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
|
Ibuprofen + Placebo to Diclofenac Potassium
n=162 Participants
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
|
|---|---|---|
|
Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at 60 Minutes Post Dose
|
47.3 units on a scale
Standard Error 2.06
|
44.1 units on a scale
Standard Error 2.08
|
SECONDARY outcome
Timeframe: 15, 30, 45, and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dosePopulation: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.
VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their current level of pain intensity on the 100 mm VASPI, labeled "no pain" (0 mm) as the left anchor and "worst possible pain" (100 mm) as the right anchor. A positive change represents a reduction in pain.
Outcome measures
| Measure |
Dilcofenac Potassium + Placebo to Ibuprofen
n=166 Participants
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
|
Ibuprofen + Placebo to Diclofenac Potassium
n=162 Participants
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
|
|---|---|---|
|
Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points
15 minutes
|
9.2 Units on a scale
Standard Error 1.55
|
13.7 Units on a scale
Standard Error 1.56
|
|
Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points
30 minutes
|
24.1 Units on a scale
Standard Error 1.96
|
26.6 Units on a scale
Standard Error 1.98
|
|
Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points
45 minutes
|
38.9 Units on a scale
Standard Error 2.16
|
36.7 Units on a scale
Standard Error 2.18
|
|
Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points
90 minutes
|
53.5 Units on a scale
Standard Error 1.98
|
49.1 Units on a scale
Standard Error 2.00
|
|
Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points
2 hours
|
55.6 Units on a scale
Standard Error 1.96
|
53.0 Units on a scale
Standard Error 1.98
|
|
Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points
4 hours
|
48.8 Units on a scale
Standard Error 2.22
|
51.9 Units on a scale
Standard Error 2.24
|
|
Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points
5 hours
|
45.4 Units on a scale
Standard Error 2.40
|
49.8 Units on a scale
Standard Error 2.42
|
|
Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points
6 hours
|
40.3 Units on a scale
Standard Error 2.58
|
46.5 Units on a scale
Standard Error 2.61
|
|
Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points
7 hours
|
35.2 Units on a scale
Standard Error 2.68
|
41.9 Units on a scale
Standard Error 2.71
|
|
Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points
8 hours
|
32.3 Units on a scale
Standard Error 2.74
|
37.7 Units on a scale
Standard Error 2.76
|
SECONDARY outcome
Timeframe: 15, 30, 45, 60 and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dosePopulation: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.
VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their pain intensity using the 100 mm VASPI to indicate their current level of pain intensity on the 100 mm VASPI labeled "no pain" (0 mm) as the left anchor and "worst possible pain" (100 mm) as the right anchor. A positive change shows reduction in pain. AUC of VASPI reduction from baseline for each time point was calculated using the trapezoidal rule.
Outcome measures
| Measure |
Dilcofenac Potassium + Placebo to Ibuprofen
n=166 Participants
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
|
Ibuprofen + Placebo to Diclofenac Potassium
n=162 Participants
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
|
|---|---|---|
|
Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points
15 minutes
|
16.1914 units on a scale*hours
Standard Error 0.19369
|
15.6262 units on a scale*hours
Standard Error 0.19558
|
|
Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points
30 minutes
|
29.3759 units on a scale*hours
Standard Error 0.58537
|
27.9216 units on a scale*hours
Standard Error 0.59109
|
|
Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points
45 minutes
|
38.8570 units on a scale*hours
Standard Error 1.03408
|
37.3448 units on a scale*hours
Standard Error 1.04418
|
|
Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points
60 minutes
|
45.4321 units on a scale*hours
Standard Error 1.48887
|
44.5882 units on a scale*hours
Standard Error 1.50342
|
|
Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points
90 minutes
|
54.9330 units on a scale*hours
Standard Error 2.34986
|
55.9885 units on a scale*hours
Standard Error 2.37282
|
|
Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points
2 hours
|
62.3674 units on a scale*hours
Standard Error 3.15839
|
65.1654 units on a scale*hours
Standard Error 3.18925
|
|
Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points
4 hours
|
96.7669 units on a scale*hours
Standard Error 6.56154
|
98.9982 units on a scale*hours
Standard Error 6.62565
|
|
Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points
5 hours
|
119.0564 units on a scale*hours
Standard Error 8.50377
|
117.4797 units on a scale*hours
Standard Error 8.58686
|
|
Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points
6 hours
|
145.6112 units on a scale*hours
Standard Error 10.58291
|
138.6947 units on a scale*hours
Standard Error 10.68631
|
|
Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points
7 hours
|
177.2751 units on a scale*hours
Standard Error 12.76115
|
163.8821 units on a scale*hours
Standard Error 12.88584
|
|
Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points
8 hours
|
212.9300 units on a scale*hours
Standard Error 15.01237
|
193.4450 units on a scale*hours
Standard Error 15.15905
|
SECONDARY outcome
Timeframe: Within 8 hours postdosePopulation: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter.
Time to onset of first perceptible pain relief (FPR), provided the FPR was subsequently 'confirmed' through the achievement of meaningful pain relief (MPR). Participant started two stopwatches at dosing, and recorded FPR by stopping the first stopwatch when he/she first experienced 'any' pain relief. FPR is 'confirmed' only if the participant also stopped the second stopwatch indicating 'meaningful pain relief'.
Outcome measures
| Measure |
Dilcofenac Potassium + Placebo to Ibuprofen
n=166 Participants
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
|
Ibuprofen + Placebo to Diclofenac Potassium
n=162 Participants
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
|
|---|---|---|
|
Time to Confirmed First Perceptible Pain Relief
|
15.81665 minutes
Interval 11.55 to 29.1333
|
14.98335 minutes
Interval 9.8833 to 22.1667
|
SECONDARY outcome
Timeframe: Within 8 hours postdosePopulation: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter.
Using the double stopwatch technique, participant started two stopwatches at dosing, and stopped the second stopwatch as soon as he/she began to experience 'meaningful' relief from pain. Time elapsed is recorded as the MPR.
Outcome measures
| Measure |
Dilcofenac Potassium + Placebo to Ibuprofen
n=166 Participants
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
|
Ibuprofen + Placebo to Diclofenac Potassium
n=162 Participants
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
|
|---|---|---|
|
Time to Onset of Meaningful Pain Relief (MPR)
|
41.67500 minutes
Interval 29.4667 to 60.1167
|
42.02500 minutes
Interval 24.9 to 73.4
|
SECONDARY outcome
Timeframe: Within 8 hours postdosePopulation: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter.
Using the double stopwatch technique, participant started two stopwatches at dosing, and stopped the first stopwatch as soon as he/she first began to feel 'any' relief from pain. The time elapsed was recorded as the FPR.
Outcome measures
| Measure |
Dilcofenac Potassium + Placebo to Ibuprofen
n=166 Participants
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
|
Ibuprofen + Placebo to Diclofenac Potassium
n=162 Participants
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
|
|---|---|---|
|
Time to Onset of First Perceptible Pain Relief (FPR)
|
15.81665 minutes
Interval 11.55 to 29.1333
|
14.85000 minutes
Interval 9.6667 to 21.3333
|
SECONDARY outcome
Timeframe: 1, 2, 4, 6, and 8 hours postdosePopulation: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.
At baseline and at each defined study time point, the clinical site staff captured pain intensity information from each subject using the 4-point categorical VRS. The subject was asked "What is your pain level at this time?" and the response was recorded as 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Pain intensity difference (PID) was the difference between the baseline pain intensity score and the pain intensity score at a specific observation point. SPID is the weighted sum of PIDs from the 15-minute to the 8-hour observation point (SPID8). Additionally, SPID evaluations were also be done at 1 (SPID1), 2 (SPID2), 4 (SPID4) and 6 (SPID6) hours post dose. The weights used for these values were 0.25 for the 15-, 30-, 45-, and 60-minute observations, and 0.5 for the 90-minute, 2- and 4-hour observations, and 1 for the remaining observations.
Outcome measures
| Measure |
Dilcofenac Potassium + Placebo to Ibuprofen
n=166 Participants
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
|
Ibuprofen + Placebo to Diclofenac Potassium
n=162 Participants
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
|
|---|---|---|
|
Sum of Pain Intensity Difference (SPID)
SPID1
|
1.077 units on a scale
Standard Error 0.0525
|
1.049 units on a scale
Standard Error 0.0530
|
|
Sum of Pain Intensity Difference (SPID)
SPID2
|
2.955 units on a scale
Standard Error 0.1050
|
2.772 units on a scale
Standard Error 0.1060
|
|
Sum of Pain Intensity Difference (SPID)
SPID4
|
6.165 units on a scale
Standard Error 0.2276
|
6.196 units on a scale
Standard Error 0.2298
|
|
Sum of Pain Intensity Difference (SPID)
SPID6
|
8.970 units on a scale
Standard Error 0.3703
|
9.323 units on a scale
Standard Error 0.3739
|
|
Sum of Pain Intensity Difference (SPID)
SPID8
|
11.099 units on a scale
Standard Error 0.5180
|
11.904 units on a scale
Standard Error 0.5230
|
SECONDARY outcome
Timeframe: 1, 2, 4, 6, and 8 hours postdosePopulation: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.
After the administration of the single dose of the assigned study treatment, at the defined study time points, the clinical site staff captured pain relief information from each subject. The subject was asked "What is the amount of pain relief as compared to the starting pain?" and the response was recorded as 0 = none, 1 = a little, 2 = some, 3 = a lot, or 4 = complete. Total pain relief (TOTPAR) was the weighted sum of the pain relief scores from the 15-minute to the 8-hour observation points (TOTPAR8). Additionally, TOTPARs at 1, 2, 4 and 6 hours were calculated. The weights used for these values (evaluation time points) were 0.25 for the 15-, 30-, 45-, and 60-minute observations, 0.5 for the 90-minute, 2- and 4-hour observations, and 1 for the remaining observations.
Outcome measures
| Measure |
Dilcofenac Potassium + Placebo to Ibuprofen
n=166 Participants
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
|
Ibuprofen + Placebo to Diclofenac Potassium
n=162 Participants
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
|
|---|---|---|
|
Summed Total Pain Relief (TOTPAR) at Different Time Points
TOTPAR1
|
1.807 units on a scale
Standard Error 0.0680
|
1.780 units on a scale
Standard Error 0.0687
|
|
Summed Total Pain Relief (TOTPAR) at Different Time Points
TOTPAR2
|
5.032 units on a scale
Standard Error 0.1452
|
4.817 units on a scale
Standard Error 0.1466
|
|
Summed Total Pain Relief (TOTPAR) at Different Time Points
TOTPAR4
|
10.642 units on a scale
Standard Error 0.3353
|
10.848 units on a scale
Standard Error 0.3385
|
|
Summed Total Pain Relief (TOTPAR) at Different Time Points
TOTPAR6
|
15.647 units on a scale
Standard Error 0.5595
|
16.499 units on a scale
Standard Error 0.5650
|
|
Summed Total Pain Relief (TOTPAR) at Different Time Points
TOTPAR8
|
19.679 units on a scale
Standard Error 0.7915
|
21.341 units on a scale
Standard Error 0.7992
|
SECONDARY outcome
Timeframe: From dose administration to 8 hours post dosePopulation: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.
Peak analgesic relief is represented through highest pain intensity difference (PID), highest VASPI reduction, and highest pain relief scores. Pain intensity was measured on a verbal rating scale (VRS) ranging from 0 to 3 (none to severe, with higher score for higher pain intensity). PID represents difference in this score at baseline and specific time points, larger change indicating larger reduction in pain, with highest PID representing the largest difference. Pain relief was recorded on a scale ranging from 0 to 4 (none to complete, with higher score for higher pain relief), with highest pain relief representing maximum relief obtained. Pain intensity was also measured through a 100 mm visual analogue scale (VASPI), ranging from "no pain" (0 mm) to "worst possible pain" (100 mm). A positive change in VASPI indicates reduction in pain, with highest VASPI reduction representing highest change.
Outcome measures
| Measure |
Dilcofenac Potassium + Placebo to Ibuprofen
n=166 Participants
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
|
Ibuprofen + Placebo to Diclofenac Potassium
n=162 Participants
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
|
|---|---|---|
|
Peak Analgesic Effect
Highest Mean PID
|
1.9 units on a scale
Standard Deviation 0.72
|
1.8 units on a scale
Standard Deviation 0.74
|
|
Peak Analgesic Effect
Highest pain relief
|
3.6 units on a scale
Standard Deviation 0.74
|
3.5 units on a scale
Standard Deviation 0.86
|
|
Peak Analgesic Effect
Highest VASPI reduction
|
61.3 units on a scale
Standard Deviation 17.99
|
60.2 units on a scale
Standard Deviation 19.35
|
SECONDARY outcome
Timeframe: From dose administration to 8 hours post dosePopulation: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter.
Duration of analgesia (time to first use of rescue medication) was evaluated, from dose administration to the time of first use of rescue medication within the 8-hour treatment period. Censored observations were included in calculating this endpoint. Censored subjects include any subject who did not take rescue medication prior to the end of the assessment period of 480 minutes (8 hours).
Outcome measures
| Measure |
Dilcofenac Potassium + Placebo to Ibuprofen
n=166 Participants
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
|
Ibuprofen + Placebo to Diclofenac Potassium
n=162 Participants
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
|
|---|---|---|
|
Duration of Analgesia
|
480.0 minutes
Interval 383.0 to 480.0
|
480.0 minutes
Interval 480.0 to 480.0
|
SECONDARY outcome
Timeframe: From dose administration to 8 hours post dosePopulation: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter.
The number of patients needing rescue medication within the 8 hour treatment period was evaluated.
Outcome measures
| Measure |
Dilcofenac Potassium + Placebo to Ibuprofen
n=166 Participants
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
|
Ibuprofen + Placebo to Diclofenac Potassium
n=162 Participants
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
|
|---|---|---|
|
Number of Patients Needing Rescue Medication
|
47 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: At 8 hour postdose prior to use of rescue medicationPopulation: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter.
PGART was measured by asking patients to give a score on a scale from 0 to 4, where 0 = poor; 1 = fair; 2 = good; 3 = very good; 4 = excellent. This measurement was taken at the end of 8 hours, or before the use of rescue medication (for a patient who takes rescue medciation within the 8 hour period).
Outcome measures
| Measure |
Dilcofenac Potassium + Placebo to Ibuprofen
n=166 Participants
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
|
Ibuprofen + Placebo to Diclofenac Potassium
n=162 Participants
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
|
|---|---|---|
|
Number of Patients With Different Responses Based on Patient's Global Assessment of Response to Treatment (PGART)
Poor (0)
|
6 Participants
|
10 Participants
|
|
Number of Patients With Different Responses Based on Patient's Global Assessment of Response to Treatment (PGART)
Fair (1)
|
7 Participants
|
7 Participants
|
|
Number of Patients With Different Responses Based on Patient's Global Assessment of Response to Treatment (PGART)
Good (2)
|
49 Participants
|
34 Participants
|
|
Number of Patients With Different Responses Based on Patient's Global Assessment of Response to Treatment (PGART)
Very good (3)
|
55 Participants
|
64 Participants
|
|
Number of Patients With Different Responses Based on Patient's Global Assessment of Response to Treatment (PGART)
Excellent (4)
|
49 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)Population: Safety analyses were performed on the safety set, which included all randomized subjects who were exposed to study drug.
Treatment emergent adverse events are reported in the below data table.
Outcome measures
| Measure |
Dilcofenac Potassium + Placebo to Ibuprofen
n=166 Participants
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
|
Ibuprofen + Placebo to Diclofenac Potassium
n=162 Participants
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
|
|---|---|---|
|
Number of Patients With Any Adverse Events, Serious Adverse Events and Death
any adverse events
|
47 Participants
|
47 Participants
|
|
Number of Patients With Any Adverse Events, Serious Adverse Events and Death
serious adverse events
|
0 Participants
|
0 Participants
|
|
Number of Patients With Any Adverse Events, Serious Adverse Events and Death
Death
|
0 Participants
|
0 Participants
|
Adverse Events
Dilcofenac Potassium + Placebo to Ibuprofen
Ibuprofen + Placebo to Diclofenac Potassium
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dilcofenac Potassium + Placebo to Ibuprofen
n=166 participants at risk
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
|
Ibuprofen + Placebo to Diclofenac Potassium
n=162 participants at risk
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/166 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
0.62%
1/162 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/166 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
0.62%
1/162 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.60%
1/166 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
0.00%
0/162 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.60%
1/166 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
0.00%
0/162 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
|
Gastrointestinal disorders
Nausea
|
4.2%
7/166 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
6.2%
10/162 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
3/166 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
0.62%
1/162 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
|
General disorders
Pyrexia
|
0.00%
0/166 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
0.62%
1/162 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
|
Investigations
Heart rate increased
|
0.60%
1/166 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
0.00%
0/162 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
|
Nervous system disorders
Dizziness
|
6.0%
10/166 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
3.1%
5/162 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
|
Nervous system disorders
Headache
|
16.3%
27/166 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
20.4%
33/162 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
|
Nervous system disorders
Hypoaesthesia
|
3.0%
5/166 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
3.1%
5/162 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
|
Nervous system disorders
Syncope
|
0.00%
0/166 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
0.62%
1/162 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/166 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
0.62%
1/162 • Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER