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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

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ClinicalTrials.gov Identifier: NCT02476422
Recruitment Status : Completed
First Posted : June 19, 2015
Results First Posted : October 17, 2016
Last Update Posted : October 17, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Post Operative Dental Pain
Interventions Drug: Diclofenac potassium
Drug: Ibuprofen
Drug: Placebo to ibuprofen
Drug: Placebo to diclofenac potassium
Enrollment 328
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dilcofenac Potassium + Placebo to Ibuprofen Ibuprofen + Placebo to Diclofenac Potassium
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 166 [1] 162
Completed 166 161
Not Completed 0 1
Reason Not Completed
Subject/guardian decision             0             1
[1]
"started" = Randomized Set/Full analysis set/Safety set
Arm/Group Title Dilcofenac Potassium + Placebo to Ibuprofen Ibuprofen + Placebo to Diclofenac Potassium Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 166 162 328
Hide Baseline Analysis Population Description
Randomized set included all subjects who were randomized into the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 166 participants 162 participants 328 participants
24.9  (5.21) 24.7  (6.11) 24.8  (5.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants 162 participants 328 participants
Female
98
  59.0%
96
  59.3%
194
  59.1%
Male
68
  41.0%
66
  40.7%
134
  40.9%
1.Primary Outcome
Title Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at 60 Minutes Post Dose
Hide Description 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.
Time Frame 60 minutes postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dilcofenac Potassium + Placebo to Ibuprofen Ibuprofen + Placebo to Diclofenac Potassium
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 166 162
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
47.3  (2.06) 44.1  (2.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dilcofenac Potassium + Placebo to Ibuprofen, Ibuprofen + Placebo to Diclofenac Potassium
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.211
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.2
Confidence Interval (2-Sided) 95%
-1.8 to 8.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points
Hide Description 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.
Time Frame 15, 30, 45, and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dilcofenac Potassium + Placebo to Ibuprofen Ibuprofen + Placebo to Diclofenac Potassium
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 166 162
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
15 minutes 9.2  (1.55) 13.7  (1.56)
30 minutes 24.1  (1.96) 26.6  (1.98)
45 minutes 38.9  (2.16) 36.7  (2.18)
90 minutes 53.5  (1.98) 49.1  (2.00)
2 hours 55.6  (1.96) 53.0  (1.98)
4 hours 48.8  (2.22) 51.9  (2.24)
5 hours 45.4  (2.40) 49.8  (2.42)
6 hours 40.3  (2.58) 46.5  (2.61)
7 hours 35.2  (2.68) 41.9  (2.71)
8 hours 32.3  (2.74) 37.7  (2.76)
3.Secondary Outcome
Title Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points
Hide Description

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.

Time Frame 15, 30, 45, 60 and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dilcofenac Potassium + Placebo to Ibuprofen Ibuprofen + Placebo to Diclofenac Potassium
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 166 162
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale*hours
15 minutes 16.1914  (0.19369) 15.6262  (0.19558)
30 minutes 29.3759  (0.58537) 27.9216  (0.59109)
45 minutes 38.8570  (1.03408) 37.3448  (1.04418)
60 minutes 45.4321  (1.48887) 44.5882  (1.50342)
90 minutes 54.9330  (2.34986) 55.9885  (2.37282)
2 hours 62.3674  (3.15839) 65.1654  (3.18925)
4 hours 96.7669  (6.56154) 98.9982  (6.62565)
5 hours 119.0564  (8.50377) 117.4797  (8.58686)
6 hours 145.6112  (10.58291) 138.6947  (10.68631)
7 hours 177.2751  (12.76115) 163.8821  (12.88584)
8 hours 212.9300  (15.01237) 193.4450  (15.15905)
4.Secondary Outcome
Title Time to Confirmed First Perceptible Pain Relief
Hide Description 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’.
Time Frame Within 8 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dilcofenac Potassium + Placebo to Ibuprofen Ibuprofen + Placebo to Diclofenac Potassium
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 166 162
Median (Inter-Quartile Range)
Unit of Measure: minutes
15.81665
(11.55000 to 29.13330)
14.98335
(9.88330 to 22.16670)
5.Secondary Outcome
Title Time to Onset of Meaningful Pain Relief (MPR)
Hide Description 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.
Time Frame Within 8 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dilcofenac Potassium + Placebo to Ibuprofen Ibuprofen + Placebo to Diclofenac Potassium
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 166 162
Median (Inter-Quartile Range)
Unit of Measure: minutes
41.67500
(29.46670 to 60.11670)
42.02500
(24.90000 to 73.40000)
6.Secondary Outcome
Title Time to Onset of First Perceptible Pain Relief (FPR)
Hide Description 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.
Time Frame Within 8 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dilcofenac Potassium + Placebo to Ibuprofen Ibuprofen + Placebo to Diclofenac Potassium
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 166 162
Median (Inter-Quartile Range)
Unit of Measure: minutes
15.81665
(11.55000 to 29.13330)
14.85000
(9.66670 to 21.33330)
7.Secondary Outcome
Title Sum of Pain Intensity Difference (SPID)
Hide Description

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.

Time Frame 1, 2, 4, 6, and 8 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dilcofenac Potassium + Placebo to Ibuprofen Ibuprofen + Placebo to Diclofenac Potassium
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 166 162
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
SPID1 1.077  (0.0525) 1.049  (0.0530)
SPID2 2.955  (0.1050) 2.772  (0.1060)
SPID4 6.165  (0.2276) 6.196  (0.2298)
SPID6 8.970  (0.3703) 9.323  (0.3739)
SPID8 11.099  (0.5180) 11.904  (0.5230)
8.Secondary Outcome
Title Summed Total Pain Relief (TOTPAR) at Different Time Points
Hide Description

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.

Time Frame 1, 2, 4, 6, and 8 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dilcofenac Potassium + Placebo to Ibuprofen Ibuprofen + Placebo to Diclofenac Potassium
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 166 162
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
TOTPAR1 1.807  (0.0680) 1.780  (0.0687)
TOTPAR2 5.032  (0.1452) 4.817  (0.1466)
TOTPAR4 10.642  (0.3353) 10.848  (0.3385)
TOTPAR6 15.647  (0.5595) 16.499  (0.5650)
TOTPAR8 19.679  (0.7915) 21.341  (0.7992)
9.Secondary Outcome
Title Peak Analgesic Effect
Hide Description 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.
Time Frame From dose administration to 8 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dilcofenac Potassium + Placebo to Ibuprofen Ibuprofen + Placebo to Diclofenac Potassium
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 166 162
Mean (Standard Deviation)
Unit of Measure: units on a scale
Highest Mean PID 1.9  (0.72) 1.8  (0.74)
Highest pain relief 3.6  (0.74) 3.5  (0.86)
Highest VASPI reduction 61.3  (17.99) 60.2  (19.35)
10.Secondary Outcome
Title Duration of Analgesia
Hide Description 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).
Time Frame From dose administration to 8 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dilcofenac Potassium + Placebo to Ibuprofen Ibuprofen + Placebo to Diclofenac Potassium
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 166 162
Median (Inter-Quartile Range)
Unit of Measure: minutes
480.0
(383.0 to 480.0)
480.0
(480.0 to 480.0)
11.Secondary Outcome
Title Number of Patients Needing Rescue Medication
Hide Description The number of patients needing rescue medication within the 8 hour treatment period was evaluated.
Time Frame From dose administration to 8 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dilcofenac Potassium + Placebo to Ibuprofen Ibuprofen + Placebo to Diclofenac Potassium
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 166 162
Measure Type: Number
Unit of Measure: Participants
47 36
12.Secondary Outcome
Title Number of Patients With Different Responses Based on Patient’s Global Assessment of Response to Treatment (PGART)
Hide Description 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).
Time Frame At 8 hour postdose prior to use of rescue medication
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dilcofenac Potassium + Placebo to Ibuprofen Ibuprofen + Placebo to Diclofenac Potassium
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 166 162
Measure Type: Number
Unit of Measure: Participants
Poor (0) 6 10
Fair (1) 7 7
Good (2) 49 34
Very good (3) 55 64
Excellent (4) 49 47
13.Secondary Outcome
Title Number of Patients With Any Adverse Events, Serious Adverse Events and Death
Hide Description Treatment emergent adverse events are reported in the below data table.
Time Frame time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analyses were performed on the safety set, which included all randomized subjects who were exposed to study drug.
Arm/Group Title Dilcofenac Potassium + Placebo to Ibuprofen Ibuprofen + Placebo to Diclofenac Potassium
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 166 162
Measure Type: Number
Unit of Measure: Participants
any adverse events 47 47
serious adverse events 0 0
Death 0 0
Time Frame Time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
Adverse Event Reporting Description The safety set consisted of all randomized subjects who were exposed to study drug. Treatment emergent adverse events are reported.
 
Arm/Group Title Dilcofenac Potassium + Placebo to Ibuprofen Ibuprofen + Placebo to Diclofenac Potassium
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Dilcofenac Potassium + Placebo to Ibuprofen Ibuprofen + Placebo to Diclofenac Potassium
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dilcofenac Potassium + Placebo to Ibuprofen Ibuprofen + Placebo to Diclofenac Potassium
Affected / at Risk (%) Affected / at Risk (%)
Total   0/166 (0.00%)   0/162 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dilcofenac Potassium + Placebo to Ibuprofen Ibuprofen + Placebo to Diclofenac Potassium
Affected / at Risk (%) Affected / at Risk (%)
Total   47/166 (28.31%)   47/162 (29.01%) 
Ear and labyrinth disorders     
Ear pain  1  0/166 (0.00%)  1/162 (0.62%) 
Gastrointestinal disorders     
Constipation  1  0/166 (0.00%)  1/162 (0.62%) 
Dyspepsia  1  1/166 (0.60%)  0/162 (0.00%) 
Gastrooesophageal reflux disease  1  1/166 (0.60%)  0/162 (0.00%) 
Nausea  1  7/166 (4.22%)  10/162 (6.17%) 
Vomiting  1  3/166 (1.81%)  1/162 (0.62%) 
General disorders     
Pyrexia  1  0/166 (0.00%)  1/162 (0.62%) 
Investigations     
Heart rate increased  1  1/166 (0.60%)  0/162 (0.00%) 
Nervous system disorders     
Dizziness  1  10/166 (6.02%)  5/162 (3.09%) 
Headache  1  27/166 (16.27%)  33/162 (20.37%) 
Hypoaesthesia  1  5/166 (3.01%)  5/162 (3.09%) 
Syncope  1  0/166 (0.00%)  1/162 (0.62%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/166 (0.00%)  1/162 (0.62%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: trialandresults.registries@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02476422     History of Changes
Other Study ID Numbers: CCAT458M2402
First Submitted: May 18, 2015
First Posted: June 19, 2015
Results First Submitted: June 29, 2016
Results First Posted: October 17, 2016
Last Update Posted: October 17, 2016