Trial Outcomes & Findings for Study of Diclofenac Capsules to Treat Dental Pain (NCT NCT00985439)
NCT ID: NCT00985439
Last Updated: 2012-05-22
Results Overview
Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-12 hours. Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
202 participants
Primary outcome timeframe
12 hours.
Results posted on
2012-05-22
Participant Flow
Participant milestones
| Measure |
Diclofenac Test (Lower Dose)
|
Diclofenac Test (Upper Dose)
|
Celecoxib 400 mg
|
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
51
|
51
|
|
Overall Study
COMPLETED
|
49
|
51
|
50
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Diclofenac Test (Lower Dose)
|
Diclofenac Test (Upper Dose)
|
Celecoxib 400 mg
|
Placebo
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of Diclofenac Capsules to Treat Dental Pain
Baseline characteristics by cohort
| Measure |
Diclofenac Test (Lower Dose)
n=49 Participants
|
Diclofenac Test (Upper Dose)
n=51 Participants
|
Celecoxib 400 mg
n=51 Participants
|
Placebo
n=51 Participants
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
202 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age Continuous
|
22.1 years
STANDARD_DEVIATION 5.10 • n=5 Participants
|
22.3 years
STANDARD_DEVIATION 4.58 • n=7 Participants
|
22.7 years
STANDARD_DEVIATION 3.30 • n=5 Participants
|
22.6 years
STANDARD_DEVIATION 4.22 • n=4 Participants
|
22.4 years
STANDARD_DEVIATION 4.32 • n=21 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
116 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
86 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
51 participants
n=7 Participants
|
51 participants
n=5 Participants
|
51 participants
n=4 Participants
|
202 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 hours.Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-12 hours. Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60.
Outcome measures
| Measure |
Diclofenac Test (Lower Dose)
n=49 Participants
18-mg
|
Diclofenac Test (Upper Dose)
n=51 Participants
35-mg
|
Celecoxib 400 mg
n=51 Participants
|
Placebo
n=51 Participants
|
|---|---|---|---|---|
|
Total Patient Pain Relief Over 0 to 12 Hours.
|
17.770 units on a scale
95% Confidence Interval 13.7607 • Interval 14.02 to 21.52
|
16.893 units on a scale
95% Confidence Interval 12.7634 • Interval 13.215 to 20.571
|
14.685 units on a scale
95% Confidence Interval 15.0524 • Interval 11.008 to 18.363
|
5.486 units on a scale
95% Confidence Interval 11.5272 • Interval 1.802 to 9.17
|
Adverse Events
Diclofenac Test (Lower Dose)
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Diclofenac Test (Upper Dose)
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Celecoxib 400 mg
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diclofenac Test (Lower Dose)
n=49 participants at risk
|
Diclofenac Test (Upper Dose)
n=51 participants at risk
|
Celecoxib 400 mg
n=51 participants at risk
|
Placebo
n=51 participants at risk
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Alveolar Osteitis
|
0.00%
0/49
|
0.00%
0/51
|
5.9%
3/51
|
7.8%
4/51
|
|
Nervous system disorders
Dizziness
|
6.1%
3/49
|
7.8%
4/51
|
5.9%
3/51
|
11.8%
6/51
|
|
Ear and labyrinth disorders
Ear Pain
|
6.1%
3/49
|
2.0%
1/51
|
3.9%
2/51
|
2.0%
1/51
|
|
Nervous system disorders
Headache
|
14.3%
7/49
|
27.5%
14/51
|
17.6%
9/51
|
19.6%
10/51
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
1/49
|
3.9%
2/51
|
5.9%
3/51
|
0.00%
0/51
|
|
Gastrointestinal disorders
Nausea
|
12.2%
6/49
|
17.6%
9/51
|
11.8%
6/51
|
7.8%
4/51
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.1%
3/49
|
5.9%
3/51
|
3.9%
2/51
|
2.0%
1/51
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
24.5%
12/49
|
21.6%
11/51
|
19.6%
10/51
|
17.6%
9/51
|
|
Injury, poisoning and procedural complications
Procedural pain
|
4.1%
2/49
|
3.9%
2/51
|
7.8%
4/51
|
2.0%
1/51
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place