Trial Outcomes & Findings for A Study of LY3023703 Testing Pain Relief After Wisdom Teeth Removal (NCT NCT01872910)

Last Updated: 2019-09-23

Results Overview

Pain intensity was rated by the participant on a 100-mm VAS: 0 mm (no pain) and 100 mm (worst pain imaginable). The participant marked the line at the point that corresponded with his or her perception of pain. Weighted mean change from baseline was calculated as: \[the area under the change in pain intensity versus time curve\] / 8 hours (h). The baseline pain intensity was the pain assessment prior to dosing of study medication (0 h). Least Squares (LS) mean were calculated using a Bayesian analysis of covariance analysis (ANCOVA) adjusted for treatment as a fixed effect and baseline pain VAS as a continuous covariate. The measure of dispersion reported is 95% Credible Interval (CrI) not Confidence Interval (CI). A negative direction indicates a pain reduction from baseline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

124 participants

Primary outcome timeframe

0 to 8 h post-dose

Results posted on

2019-09-23

Participant Flow

Participants were randomized to treatment groups when their dental pain intensity post oral surgery was moderate (or severe) as reported on a categorical 4-point scale: 0 (absent) to 3 (severe) and were marked on a 100 millimeter (mm) straight line visual analog scale (VAS) with a pain score ≥40 mm: 0 mm (no pain) to 100 mm (worst pain imaginable).

Participant milestones

Participant milestones
Measure	Part A - LY3023703 LY3023703: Administered orally once as a 30-milligrams (mg) capsule post dental surgery.	Part A - Celecoxib Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).	Part A - Placebo Placebo: Administered orally once as a capsule post dental surgery.	Part B - LY3023703 LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.	Part B - Placebo Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.	Pre-Part B - Celecoxib Celecoxib: Administered orally once as two 200-mg capsules, post dental surgery and post dialysate probe placement. Prior to Part B, there was a technique transfer and training conducted to allow the site to develop proficiency in dialysate placement, collection and maintenance techniques.
Overall Study STARTED	30	31	30	15	15	3
Overall Study Received Any Study Drug	30	31	30	15	15	3
Overall Study COMPLETED	28	31	28	15	15	3
Overall Study NOT COMPLETED	2	0	2	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A - LY3023703 LY3023703: Administered orally once as a 30-milligrams (mg) capsule post dental surgery.	Part A - Celecoxib Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).	Part A - Placebo Placebo: Administered orally once as a capsule post dental surgery.	Part B - LY3023703 LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.	Part B - Placebo Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.	Pre-Part B - Celecoxib Celecoxib: Administered orally once as two 200-mg capsules, post dental surgery and post dialysate probe placement. Prior to Part B, there was a technique transfer and training conducted to allow the site to develop proficiency in dialysate placement, collection and maintenance techniques.
Overall Study Lost to Follow-up	2	0	2	0	0	0

Baseline Characteristics

A Study of LY3023703 Testing Pain Relief After Wisdom Teeth Removal

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A - LY3023703 n=30 Participants LY3023703: Administered orally once as a 30-mg capsule post dental surgery.	Part A - Celecoxib n=31 Participants Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).	Part A - Placebo n=30 Participants Placebo: Administered orally once as a capsule post dental surgery.	Part B - LY3023703 n=15 Participants LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.	Part B - Placebo n=15 Participants Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.	Pre-Part B - Celecoxib n=3 Participants Celecoxib: Administered orally once as two 200-mg capsules, post dental surgery and post dialysate probe placement.	Total n=124 Participants Total of all reporting groups
Age, Continuous	22.5 years STANDARD_DEVIATION 3.4 • n=5 Participants	22.9 years STANDARD_DEVIATION 4.3 • n=7 Participants	22.9 years STANDARD_DEVIATION 3.5 • n=5 Participants	22.3 years STANDARD_DEVIATION 3.2 • n=4 Participants	24.8 years STANDARD_DEVIATION 2.6 • n=21 Participants	24.3 years STANDARD_DEVIATION 2.5 • n=8 Participants	22.98 years STANDARD_DEVIATION 3.593 • n=8 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	19 Participants n=7 Participants	16 Participants n=5 Participants	10 Participants n=4 Participants	11 Participants n=21 Participants	2 Participants n=8 Participants	75 Participants n=8 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	1 Participants n=8 Participants	49 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	10 Participants n=4 Participants	6 Participants n=21 Participants	1 Participants n=8 Participants	47 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	21 Participants n=7 Participants	19 Participants n=5 Participants	5 Participants n=4 Participants	9 Participants n=21 Participants	2 Participants n=8 Participants	77 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	6 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	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	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	24 Participants n=7 Participants	23 Participants n=5 Participants	14 Participants n=4 Participants	13 Participants n=21 Participants	3 Participants n=8 Participants	101 Participants n=8 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	13 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	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	0 Participants n=8 Participants
Region of Enrollment United States	30 participants n=5 Participants	31 participants n=7 Participants	30 participants n=5 Participants	15 participants n=4 Participants	15 participants n=21 Participants	3 participants n=8 Participants	124 participants n=8 Participants
VAS Pain Score at Post-Surgery Pre-Randomization	69.7 mm STANDARD_DEVIATION 13.1 • n=5 Participants	77.0 mm STANDARD_DEVIATION 13.7 • n=7 Participants	70.5 mm STANDARD_DEVIATION 10.7 • n=5 Participants	75.1 mm STANDARD_DEVIATION 13.0 • n=4 Participants	67.0 mm STANDARD_DEVIATION 6.1 • n=21 Participants	72.6 mm STANDARD_DEVIATION 12.9 • n=8 Participants	72.7 mm STANDARD_DEVIATION 12.7 • n=8 Participants

PRIMARY outcome

Timeframe: 0 to 8 h post-dose

Population: Full Analysis Set (FAS): Part A participants who were randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 postdose efficacy assessment. Pain assessments after rescue medication were imputed using last observation carried forward (LOCF) from the pain assessment prior to rescue therapy.

Outcome measures

Outcome measures
Measure	Part A - LY3023703 n=30 Participants LY3023703: Administered orally once as a 30-mg capsule post dental surgery.	Part A - Celecoxib n=31 Participants Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).	Part A - Placebo n=30 Participants Placebo: Administered orally once as a capsule post dental surgery.	Part B - LY3023703 LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.	Part B - Placebo Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.
Part A: Weighted Mean Change From Baseline in Pain Intensity Over the First 8 Hours Post-Dose Using VAS	-3.8 mm Interval -11.4 to 4.0	-47.4 mm Interval -55.2 to -39.4	-12.7 mm Interval -20.6 to -4.8	—	—

SECONDARY outcome

Timeframe: 0 to 4, 0 to 6, 0 to 8, 0 to 12, and 0 to 24 h post-dose

Population: FAS: All data from all participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Pain assessments after rescue medication were imputed using LOCF from the pain assessment prior to rescue therapy excluding Pre-Part B.

TOPAR was calculated as the area under the pain relief versus time curve of the participant reported pain relief scores from the 5-point pain relief scale of 0 (no pain relief) to 4 (complete pain relief). LS mean were calculated using ANCOVA adjusted for treatment as a fixed effect. The measure of dispersion reported is CrI not CI. A negative direction indicated a pain relief from baseline. Pre-Part B used 3 participants in order for the study site to develop proficiency in the dialysate placement, collection, and maintenance techniques. There were no planned efficacy analysis for Pre-Part B per protocol.

Outcome measures

Outcome measures
Measure	Part A - LY3023703 n=30 Participants LY3023703: Administered orally once as a 30-mg capsule post dental surgery.	Part A - Celecoxib n=31 Participants Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).	Part A - Placebo n=30 Participants Placebo: Administered orally once as a capsule post dental surgery.	Part B - LY3023703 n=15 Participants LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.	Part B - Placebo n=15 Participants Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.
Total Pain Relief (TOPAR) Score at 4, 6, 8, 12 and 24 Hours Post-Dose 0 to 24 h	17.9 pain relief * h Interval 7.8 to 27.9	57.3 pain relief * h Interval 47.2 to 67.1	34.2 pain relief * h Interval 24.2 to 44.2	5.4 pain relief * h Interval -4.8 to 15.8	12.4 pain relief * h Interval 2.3 to 22.6
Total Pain Relief (TOPAR) Score at 4, 6, 8, 12 and 24 Hours Post-Dose 0 to 4 h	2.2 pain relief * h Interval 1.1 to 3.3	8.1 pain relief * h Interval 7.0 to 9.2	3.6 pain relief * h Interval 2.5 to 4.7	1.1 pain relief * h Interval 0.0 to 2.2	1.1 pain relief * h Interval 0.0 to 2.2
Total Pain Relief (TOPAR) Score at 4, 6, 8, 12 and 24 Hours Post-Dose 0 to 6 h	3.8 pain relief * h Interval 1.9 to 5.7	13.4 pain relief * h Interval 11.5 to 15.2	6.3 pain relief * h Interval 4.4 to 8.2	1.8 pain relief * h Interval -0.2 to 3.7	2.0 pain relief * h Interval 0.1 to 3.9
Total Pain Relief (TOPAR) Score at 4, 6, 8, 12 and 24 Hours Post-Dose 0 to 8 h	5.2 pain relief * h Interval 2.5 to 8.0	18.4 pain relief * h Interval 15.7 to 21.0	9.2 pain relief * h Interval 6.5 to 12.0	2.3 pain relief * h Interval -0.5 to 5.1	3.1 pain relief * h Interval 0.3 to 5.8
Total Pain Relief (TOPAR) Score at 4, 6, 8, 12 and 24 Hours Post-Dose 0 to 12 h	8.3 pain relief * h Interval 3.8 to 12.7	28.0 pain relief * h Interval 23.6 to 32.3	15.1 pain relief * h Interval 10.6 to 19.7	3.1 pain relief * h Interval -1.3 to 7.6	5.2 pain relief * h Interval 0.7 to 9.6

SECONDARY outcome

Timeframe: Part A and B: 0 to 4, 0 to 6, 0 to 12, and 0 to 24 h post-dose and Part B 0 to 8 h post-dose

Pain intensity was rated by the participant on a 100-mm VAS: 0 mm (no pain) and 100 mm (worst pain imaginable). The participant marked the line at the point that corresponded with his or her perception of post oral surgery pain. Weighted mean change from baseline was calculated as: \[area under the change in pain intensity versus time curve\] / \[time period that is (i.e.) 24 h for 0 to 24 h endpoint\]. The baseline pain intensity was the pain assessment prior to dosing of study medication. LS mean were calculated using ANCOVA adjusted for treatment, time and interaction of treatment as a fixed effect and baseline pain VAS as a continuous covariate. The measure of dispersion reported is the 95% CrI not CI. A negative direction indicated a pain reduction from baseline. Pre-Part B used 3 participants in order for the study site to develop proficiency in the dialysate placement, collection, and maintenance techniques. There were no planned efficacy analysis for Pre-Part B per protocol.

Outcome measures

Outcome measures
Measure	Part A - LY3023703 n=30 Participants LY3023703: Administered orally once as a 30-mg capsule post dental surgery.	Part A - Celecoxib n=31 Participants Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).	Part A - Placebo n=30 Participants Placebo: Administered orally once as a capsule post dental surgery.	Part B - LY3023703 n=15 Participants LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.	Part B - Placebo n=15 Participants Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.
Weighted Mean Change From Baseline in Pain Intensity Over the First 24 Hours Post-Dose as Measured by VAS 0 to 4 h	-3.2 mm Interval -9.7 to 3.2	-40.5 mm Interval -47.0 to -33.8	-8.5 mm Interval -15.1 to -1.6	1.0 mm Interval -6.9 to 9.1	-0.6 mm Interval -8.5 to 7.5
Weighted Mean Change From Baseline in Pain Intensity Over the First 24 Hours Post-Dose as Measured by VAS 0 to 6 h	-3.6 mm Interval -10.9 to 3.5	-46.1 mm Interval -53.4 to -38.7	-10.9 mm Interval -18.3 to -3.7	1.7 mm Interval -7.8 to 11.1	-1.8 mm Interval -11.3 to 7.7
Weighted Mean Change From Baseline in Pain Intensity Over the First 24 Hours Post-Dose as Measured by VAS 0 to 8 h	NA mm Part A results are contained in Outcome Measure 1.	NA mm Part A results are contained in Outcome Measure 1.	NA mm Part A results are contained in Outcome Measure 1.	2.1 mm Interval -8.1 to 12.4	-2.3 mm Interval -12.4 to 7.9
Weighted Mean Change From Baseline in Pain Intensity Over the First 24 Hours Post-Dose as Measured by VAS 0 to 12 h	-4.0 mm Interval -12.4 to 4.7	-47.5 mm Interval -56.1 to -38.8	-14.7 mm Interval -23.2 to -6.1	1.0 mm Interval -6.9 to 9.1	-0.6 mm Interval -8.5 to 7.5
Weighted Mean Change From Baseline in Pain Intensity Over the First 24 Hours Post-Dose as Measured by VAS 0 to 24 h	-5.2 mm Interval -15.2 to 4.6	-47.9 mm Interval -57.4 to -38.2	-17.7 mm Interval -27.5 to -8.0	3.9 mm Interval -7.8 to 15.5	-4.0 mm Interval -15.6 to 7.5

SECONDARY outcome

Timeframe: 0 to 4, 0 to 6, 0 to 8, 0 to 12, and 0 to 24 h post-dose

The summed (time-weighted) pain intensity difference to baseline (SPID) at 4, 6, 8, 12, and 24 h post-dosing, as measured by a participant-rated 4-point categorical scale of 0 (no pain) to 3 (severe pain) and was calculated as: the area under the change in pain intensity versus time curve. Total scores range: -24 (best) to 8 (worst) for SPID 0 to 8 h. Score ranges for SPID(0-4h), SPID(0-6), SPID(0-12) and SPID(0-24) are -12 to 4, -18 to 6, -36 to 12 and -72 to 24 respectively. Participants were required to have moderate (score=2) or severe (score=3) pain at baseline in order to be eligible for randomization.LS mean were calculated using ANCOVA and was adjusted for treatment as a fixed effect and baseline pain intensity as a continuous covariate. The measure of dispersion reported is 95% CrI not CI. A negative direction indicated a pain reduction from baseline. There were no planned efficacy analysis for Pre-Part B per protocol.

Outcome measures

Outcome measures
Measure	Part A - LY3023703 n=30 Participants LY3023703: Administered orally once as a 30-mg capsule post dental surgery.	Part A - Celecoxib n=31 Participants Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).	Part A - Placebo n=30 Participants Placebo: Administered orally once as a capsule post dental surgery.	Part B - LY3023703 n=15 Participants LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.	Part B - Placebo n=15 Participants Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.
Summed Pain Intensity Difference (SPID) Over the First 24 Hours Post-Dose as Measured by a 4-point Categorical Scale 0 to 4 h	-0.6 units on a scale Interval -1.5 to 0.3	-4.1 units on a scale Interval -5.0 to -3.2	-1.2 units on a scale Interval -2.1 to -0.3	0.0 units on a scale Interval -0.9 to 1.0	0.3 units on a scale Interval -0.6 to 1.3
Summed Pain Intensity Difference (SPID) Over the First 24 Hours Post-Dose as Measured by a 4-point Categorical Scale 0 to 8 h	-1.3 units on a scale Interval -3.4 to 0.7	-9.4 units on a scale Interval -11.4 to -7.3	-3.2 units on a scale Interval -5.3 to -1.2	0.3 units on a scale Interval -1.9 to 2.5	0.1 units on a scale Interval -2.1 to 2.4
Summed Pain Intensity Difference (SPID) Over the First 24 Hours Post-Dose as Measured by a 4-point Categorical Scale 0 to 6 h	-1.0 units on a scale Interval -2.5 to 0.5	-6.9 units on a scale Interval -8.4 to -5.5	-2.1 units on a scale Interval -3.6 to -0.7	0.2 units on a scale Interval -1.4 to 1.7	0.2 units on a scale Interval -1.3 to 1.8
Summed Pain Intensity Difference (SPID) Over the First 24 Hours Post-Dose as Measured by a 4-point Categorical Scale 0 to 12 h	-2.1 units on a scale Interval -5.4 to 1.2	-13.7 units on a scale Interval -17.1 to -10.4	-5.5 units on a scale Interval -8.8 to -2.2	0.7 units on a scale Interval -2.8 to 4.2	-0.2 units on a scale Interval -3.6 to 3.2
Summed Pain Intensity Difference (SPID) Over the First 24 Hours Post-Dose as Measured by a 4-point Categorical Scale 0 to 24 h	-5.2 units on a scale Interval -12.5 to 2.4	-27.1 units on a scale Interval -34.4 to -19.8	-13.0 units on a scale Interval -20.2 to -5.6	2.4 units on a scale Interval -5.4 to 10.1	-1.7 units on a scale Interval -9.4 to 5.9

SECONDARY outcome

Timeframe: Study drug administration to first use of rescue medication (0 to 24 h post-dose)

Population: FAS: All data from all participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Participants censored: Part A: LY3023703=5, Celecoxib=18, Placebo=12, Part B: LY3023703=0, Placebo=2.

Time to first use of rescue medication is defined as the time from study drug administration to the measured first use of rescue medication in hours. Participants were censored at 24 h post-dose if no rescue medication was administered. Pre-Part B used 3 participants in order for the study site to develop proficiency in the dialysate placement, collection, and maintenance techniques. There were no planned efficacy analysis for Pre-Part B per protocol.

Outcome measures

Outcome measures
Measure	Part A - LY3023703 n=30 Participants LY3023703: Administered orally once as a 30-mg capsule post dental surgery.	Part A - Celecoxib n=31 Participants Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).	Part A - Placebo n=30 Participants Placebo: Administered orally once as a capsule post dental surgery.	Part B - LY3023703 n=15 Participants LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.	Part B - Placebo n=15 Participants Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.
Time to First Use of Rescue Medication	1.8 h Interval 1.7 to 2.3	NA h Interval 8.3 to Median and upper limit of CI were not calculated, less than 50% of participants received rescue medication.	2.9 h Interval 1.8 to Upper limit of CI was not calculated, less than 50% of participants received rescue medication.	1.9 h Interval 1.7 to 1.9	1.8 h Interval 1.8 to 2.2

SECONDARY outcome

Timeframe: Study drug administration to first perceptible pain relief (0 to 24 h post-dose)

Population: FAS: Part A participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Participants censored: Part A: LY3023703=11, Celecoxib=2, Placebo=9.

Time to onset of the first perceptible pain relief is defined as the time from study drug administration to the measured onset of first perceptible pain relief in hours as reported by the participant. Participants who received rescue mediation prior to first perceptible pain relief were censored at the time the rescue medication was received.

Outcome measures

Outcome measures
Measure	Part A - LY3023703 n=30 Participants LY3023703: Administered orally once as a 30-mg capsule post dental surgery.	Part A - Celecoxib n=31 Participants Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).	Part A - Placebo n=30 Participants Placebo: Administered orally once as a capsule post dental surgery.	Part B - LY3023703 LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.	Part B - Placebo Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.
Part A: Time to Onset of First Perceptible Pain Relief	0.9 h Interval 0.6 to 2.2	0.7 h Interval 0.4 to 0.8	1.0 h Interval 0.4 to 1.6	—	—

SECONDARY outcome

Timeframe: Study drug administration to meaningful pain relief (0 to 24 h post-dose)

Time to onset of meaningful pain relief is defined as the time from study drug administration to the measured onset of meaningful pain relief in hours as reported by the participant. Participants who received rescue mediation prior to meaningful pain relief were censored at the time the rescue medication was received.

Outcome measures

Outcome measures
Measure	Part A - LY3023703 n=30 Participants LY3023703: Administered orally once as a 30-mg capsule post dental surgery.	Part A - Celecoxib n=31 Participants Celecoxib: Administered orally once as two 200-mg capsules post dental surgery (Positive control).	Part A - Placebo n=29 Participants Placebo: Administered orally once as a capsule post dental surgery.	Part B - LY3023703 LY3023703: Administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement.	Part B - Placebo Placebo: Administered orally once as a capsule, post dental surgery and post dialysate probe placement.
Part A: Time to Onset of Meaningful Pain Relief	3.8 h Interval 3.0 to 3.8	1.2 h Interval 0.9 to 1.4	2.2 h Interval 1.6 to 4.9	—	—

SECONDARY outcome

Timeframe: 2, 4, 8, 12 and 24 h post-dose

Population: Part A participants who were randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose PGI-I assessment. Participants who received rescue medication were not included in the specific timepoints post administration of rescue medication.

PGI-I is a participant-rated instrument that measures the improvement of the participants symptoms on a 7-point scale: 1 (very much improved), 4 (no change), and 7 (very much worse). LS mean was calculated using Mixed Effect Model Repeated Measures (MMRM) adjusted for treatment, time, the interaction of treatment and time and baseline pain VAS and fixed effects.