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Trial Outcomes & Findings for Phase 2 Study of Indomethacin Capsules to Treat Dental Pain (NCT NCT00964431)

NCT ID: NCT00964431

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 0-8 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 32.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

203 participants

Primary outcome timeframe

8 hours

Results posted on

2012-05-22

Participant Flow

Participant milestones

Participant milestones
Measure
Indomethacin Test (Lower Dose)
Indomethacin Test (Upper Dose)
Single dose
Celecoxib 400 mg
Placebo
Overall Study
STARTED
50
51
51
51
Overall Study
COMPLETED
50
51
51
51
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 2 Study of Indomethacin Capsules to Treat Dental Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Indomethacin Test (Lower Dose)
n=50 Participants
Indomethacin Test (Upper Dose)
n=51 Participants
Single dose
Celecoxib 400 mg
n=51 Participants
Placebo
n=51 Participants
Total
n=203 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
Age, Categorical
Between 18 and 65 years
50 Participants
n=93 Participants
51 Participants
n=4 Participants
51 Participants
n=27 Participants
51 Participants
n=483 Participants
203 Participants
n=36 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
Age Continuous
22.0 years
STANDARD_DEVIATION 3.32 • n=93 Participants
22.2 years
STANDARD_DEVIATION 3.81 • n=4 Participants
22.1 years
STANDARD_DEVIATION 3.46 • n=27 Participants
22.1 years
STANDARD_DEVIATION 2.97 • n=483 Participants
22.1 years
STANDARD_DEVIATION 3.38 • n=36 Participants
Sex: Female, Male
Female
32 Participants
n=93 Participants
31 Participants
n=4 Participants
34 Participants
n=27 Participants
35 Participants
n=483 Participants
132 Participants
n=36 Participants
Sex: Female, Male
Male
18 Participants
n=93 Participants
20 Participants
n=4 Participants
17 Participants
n=27 Participants
16 Participants
n=483 Participants
71 Participants
n=36 Participants
Region of Enrollment
United States
50 participants
n=93 Participants
51 participants
n=4 Participants
51 participants
n=27 Participants
51 participants
n=483 Participants
203 participants
n=36 Participants

PRIMARY outcome

Timeframe: 8 hours

Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-8 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 32.

Outcome measures

Outcome measures
Measure
Indomethacin Test (Lower Dose)
n=50 Participants
20-mg
Indomethacin Test (Upper Dose)
n=51 Participants
40-mg
Celecoxib 400 mg
n=51 Participants
Placebo
n=51 Participants
Total Patient Pain Relief Over 0 to 8 Hours.
10.794 units on a scale
Interval 8.131 to 13.456
12.564 units on a scale
Interval 9.928 to 15.2
14.822 units on a scale
Interval 12.185 to 17.46
3.019 units on a scale
Interval 0.381 to 5.656

Adverse Events

Indomethacin Test (Lower Dose)

Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths

Indomethacin Test (Upper Dose)

Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths

Celecoxib 400 mg

Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Indomethacin Test (Lower Dose)
n=50 participants at risk
Indomethacin Test (Upper Dose)
n=51 participants at risk
Single dose
Celecoxib 400 mg
n=51 participants at risk
Placebo
n=51 participants at risk
Gastrointestinal disorders
Alveolar osteitis
4.0%
2/50
9.8%
5/51
9.8%
5/51
7.8%
4/51
Nervous system disorders
Dizziness
0.00%
0/50
3.9%
2/51
0.00%
0/51
7.8%
4/51
Nervous system disorders
Headache
6.0%
3/50
7.8%
4/51
7.8%
4/51
15.7%
8/51
Nervous system disorders
Nausea
16.0%
8/50
11.8%
6/51
9.8%
5/51
23.5%
12/51
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
2.0%
1/50
7.8%
4/51
5.9%
3/51
2.0%
1/51
Injury, poisoning and procedural complications
Post procedural swelling
6.0%
3/50
9.8%
5/51
5.9%
3/51
7.8%
4/51
Gastrointestinal disorders
Vomiting
4.0%
2/50
9.8%
5/51
3.9%
2/51
3.9%
2/51

Additional Information

Steven Jensen

Iroko Pharmaceuticals, LLC

Phone: 267-546-3003

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place