Trial Outcomes & Findings for Study of Naproxen Capsules to Treat Dental Pain (NCT NCT01229228)
NCT ID: NCT01229228
Last Updated: 2012-05-22
Results Overview
Total pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint 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
254 participants
Primary outcome timeframe
Over 0 to 12 Hours
Results posted on
2012-05-22
Participant Flow
Participant milestones
| Measure |
Naproxen Test (Lower Dose)
|
Naproxen Test (Upper Dose)
|
Naprosyn 250 mg
|
Naprosyn 500 mg
|
Placebo
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
50
|
51
|
51
|
|
Overall Study
COMPLETED
|
50
|
51
|
49
|
51
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Naproxen Capsules to Treat Dental Pain
Baseline characteristics by cohort
| Measure |
Naproxen Test (Lower Dose)
n=51 Participants
|
Naproxen Test (Upper Dose)
n=51 Participants
|
Naprosyn 250 mg
n=50 Participants
|
Naprosyn 500 mg
n=51 Participants
|
Placebo
n=51 Participants
|
Total
n=254 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
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
254 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Age Continuous
|
21.1 years
STANDARD_DEVIATION 2.93 • n=5 Participants
|
21.1 years
STANDARD_DEVIATION 3.29 • n=7 Participants
|
20.7 years
STANDARD_DEVIATION 2.20 • n=5 Participants
|
20.9 years
STANDARD_DEVIATION 2.88 • n=4 Participants
|
21.1 years
STANDARD_DEVIATION 3.02 • n=21 Participants
|
21.0 years
STANDARD_DEVIATION 2.87 • n=8 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
148 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
106 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
51 participants
n=7 Participants
|
50 participants
n=5 Participants
|
51 participants
n=4 Participants
|
51 participants
n=21 Participants
|
254 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Over 0 to 12 HoursTotal pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint 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 |
Naproxen Test (Lower Dose)
n=50 Participants
200-mg single dose
|
Naproxen Test (Upper Dose)
n=51 Participants
400-mg (2 x 200-mg)
|
Naprosyn 250 mg
n=50 Participants
|
Naprosyn 500 mg
n=51 Participants
|
Placebo
n=51 Participants
|
|---|---|---|---|---|---|
|
Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0
|
25.868 units on a scale
Interval 21.943 to 29.792
|
31.948 units on a scale
Interval 28.065 to 35.831
|
24.373 units on a scale
Interval 20.442 to 28.304
|
28.549 units on a scale
Interval 24.66 to 32.439
|
9.531 units on a scale
Interval 5.646 to 13.416
|
Adverse Events
Naproxen Test (Lower Dose)
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Naproxen Test (Upper Dose)
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Naprosyn 250 mg
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Naprosyn 500 mg
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Naproxen Test (Lower Dose)
n=51 participants at risk；n=50 participants at risk
|
Naproxen Test (Upper Dose)
n=51 participants at risk
|
Naprosyn 250 mg
n=50 participants at risk
|
Naprosyn 500 mg
n=51 participants at risk
|
Placebo
n=51 participants at risk
|
|---|---|---|---|---|---|
|
General disorders
Adverse drug reaction
|
2.0%
1/50
|
0.00%
0/51
|
0.00%
0/50
|
0.00%
0/51
|
0.00%
0/51
|
Other adverse events
| Measure |
Naproxen Test (Lower Dose)
n=51 participants at risk；n=50 participants at risk
|
Naproxen Test (Upper Dose)
n=51 participants at risk
|
Naprosyn 250 mg
n=50 participants at risk
|
Naprosyn 500 mg
n=51 participants at risk
|
Placebo
n=51 participants at risk
|
|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
9.8%
5/51
|
5.9%
3/51
|
4.0%
2/50
|
0.00%
0/51
|
11.8%
6/51
|
|
Nervous system disorders
Headache
|
9.8%
5/51
|
11.8%
6/51
|
12.0%
6/50
|
9.8%
5/51
|
17.6%
9/51
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.00%
0/51
|
5.9%
3/51
|
0.00%
0/50
|
2.0%
1/51
|
3.9%
2/51
|
|
Gastrointestinal disorders
Nausea
|
11.8%
6/51
|
3.9%
2/51
|
16.0%
8/50
|
11.8%
6/51
|
17.6%
9/51
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/51
|
7.8%
4/51
|
6.0%
3/50
|
2.0%
1/51
|
5.9%
3/51
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
31.4%
16/51
|
23.5%
12/51
|
22.0%
11/50
|
29.4%
15/51
|
17.6%
9/51
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/51
|
0.00%
0/51
|
2.0%
1/50
|
2.0%
1/51
|
5.9%
3/51
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place