Trial Outcomes & Findings for Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain (NCT NCT02084511)
NCT ID: NCT02084511
Last Updated: 2019-04-12
Results Overview
Time-weighted sum of pain intensity difference (PID) from 0 to 8 hours post drug administration (SPID0-8h). SPID0-8h: possible range (-400; 800). The greater SPID0-8 the greater the reduction of pain intensity over the first 8 hours post drug administration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
80 participants
Primary outcome timeframe
up to 8 hours post drug administration
Results posted on
2019-04-12
Participant Flow
This was a randomised, placebo and active comparator-controlled, partially double-blinded, single-dose, parallel-group, single-centre trial in male patients in double dummy design investigating 4 different treatments.
Participant milestones
| Measure |
BI 50 mg PfOS
This trial has double dummy design, thus subjects were orally administered single dose of 50 mg of Boehringer Ingelheim (BI) 1026706 powder for oral solution (PfOS) with 200 mL of water plus matching placebo to BI 1026706 PfOS (to have 80 mL volume in total) and a placebo film-coated tablet.
|
BI 200 mg PfOS
This trial has double dummy design, thus subjects were orally administered single dose of 200 mg of BI 1026706 powder for oral solution (PfOS) with 200 mL of water and a placebo film-coated tablet.
|
Placebo
This trial has double dummy design, thus subjects were orally administered single dose of matching placebo to BI 1026706 powder for oral solution with 200 mL of water and placebo film coated tablet.
|
Celecoxib 200 mg
This trial has double dummy design, thus subjects were orally administered single dose of Celecoxib hard capsule of 200 mg with 200 mL of water plus matching placebo to BI 1026706 PfOS.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain
Baseline characteristics by cohort
| Measure |
BI 50 mg PfOS
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of 50 mg of Boehringer Ingelheim (BI) 1026706 powder for oral solution (PfOS) with 200 mL of water plus matching placebo to BI 1026706 PfOS (to have 80 mL volume in total) and a placebo film-coated tablet.
|
BI 200 mg PfOS
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of 200 mg of BI 1026706 powder for oral solution (PfOS) with 200 mL of water and a placebo film-coated tablet.
|
Placebo
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of matching placebo to BI 1026706 powder for oral solution with 200 mL of water and placebo film coated tablet.
|
Celecoxib 200 mg
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of Celecoxib hard capsule of 200 mg with 200 mL of water plus matching placebo to BI 1026706 PfOS.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
27.0 Years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
24.2 Years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
26.9 Years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
26.5 Years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
26.1 Years
STANDARD_DEVIATION 7.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
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
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: up to 8 hours post drug administrationPopulation: The pharmacodynamic set (PD set) included all subjects of the Treated set (TS) who provided at least 1 primary or secondary PD endpoint value that was not flagged for exclusion.
Time-weighted sum of pain intensity difference (PID) from 0 to 8 hours post drug administration (SPID0-8h). SPID0-8h: possible range (-400; 800). The greater SPID0-8 the greater the reduction of pain intensity over the first 8 hours post drug administration.
Outcome measures
| Measure |
BI 50 mg PfOS
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of 50 mg of Boehringer Ingelheim (BI) 1026706 powder for oral solution (PfOS) with 200 mL of water plus matching placebo to BI 1026706 PfOS (to have 80 mL volume in total) and a placebo film-coated tablet.
|
BI 200 mg PfOS
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of 200 mg of BI 1026706 powder for oral solution (PfOS) with 200 mL of water and a placebo film-coated tablet.
|
Placebo
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of matching placebo to BI 1026706 powder for oral solution with 200 mL of water and placebo film coated tablet.
|
Celecoxib 200 mg
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of Celecoxib hard capsule of 200 mg with 200 mL of water plus matching placebo to BI 1026706 PfOS.
|
|---|---|---|---|---|
|
SPID0-8h
|
-50.14 units on scale
Interval -123.5 to 23.2
|
-24.06 units on scale
Interval -97.4 to 49.3
|
-77.54 units on scale
Interval -150.9 to -4.2
|
124.47 units on scale
Interval 51.1 to 197.8
|
SECONDARY outcome
Timeframe: up to 8 hours post drug administrationPopulation: PD Set
Time-weighted total pain relief (PAR) from 0 to 8 hours (TOTPAR0-8h). (TOTPAR0-8h)TOTPAR0-8h: possible range (0;32). The greater TOTPAR0-8h the more pain relief was experienced over the first 8 hours post drug administration.
Outcome measures
| Measure |
BI 50 mg PfOS
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of 50 mg of Boehringer Ingelheim (BI) 1026706 powder for oral solution (PfOS) with 200 mL of water plus matching placebo to BI 1026706 PfOS (to have 80 mL volume in total) and a placebo film-coated tablet.
|
BI 200 mg PfOS
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of 200 mg of BI 1026706 powder for oral solution (PfOS) with 200 mL of water and a placebo film-coated tablet.
|
Placebo
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of matching placebo to BI 1026706 powder for oral solution with 200 mL of water and placebo film coated tablet.
|
Celecoxib 200 mg
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of Celecoxib hard capsule of 200 mg with 200 mL of water plus matching placebo to BI 1026706 PfOS.
|
|---|---|---|---|---|
|
TOTPAR0-8h
|
3.85 units on scale
Interval 1.0 to 6.7
|
3.14 units on scale
Interval 0.3 to 6.0
|
2.16 units on scale
Interval -0.7 to 5.0
|
10.12 units on scale
Interval 7.3 to 13.0
|
SECONDARY outcome
Timeframe: up to 2 hours post drug administrationPopulation: PD set
Time-weighted sum of PID from 0 to 2 hours (SPID0-2h). SPID0-2h: possible range (-100; 200). The greater SPID0-2 the greater the reduction of pain intensity over the first 2 hours post drug administration.
Outcome measures
| Measure |
BI 50 mg PfOS
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of 50 mg of Boehringer Ingelheim (BI) 1026706 powder for oral solution (PfOS) with 200 mL of water plus matching placebo to BI 1026706 PfOS (to have 80 mL volume in total) and a placebo film-coated tablet.
|
BI 200 mg PfOS
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of 200 mg of BI 1026706 powder for oral solution (PfOS) with 200 mL of water and a placebo film-coated tablet.
|
Placebo
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of matching placebo to BI 1026706 powder for oral solution with 200 mL of water and placebo film coated tablet.
|
Celecoxib 200 mg
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of Celecoxib hard capsule of 200 mg with 200 mL of water plus matching placebo to BI 1026706 PfOS.
|
|---|---|---|---|---|
|
SPID0-2h
|
-8.08 units on scale
Interval -23.6 to 7.4
|
6.57 units on scale
Interval -8.9 to 22.1
|
-14.01 units on scale
Interval -29.5 to 1.5
|
5.20 units on scale
Interval -10.3 to 20.7
|
SECONDARY outcome
Timeframe: up to 10 hours post drug administrationPopulation: PD set
Time to meaningful pain relief was captured by a stopwatch started by the trial staff immediately after administration of study medication and stopped by the subject as soon as a meaningful pain relief was felt by the subject. If a subject did not have any meaningful pain relief up to 10 h, the time was censored at 10 h. Kaplan-Meier estimates over time for each treatment and time to event endpoint 'Time to meaningful pain relief' were presented descriptively.
Outcome measures
| Measure |
BI 50 mg PfOS
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of 50 mg of Boehringer Ingelheim (BI) 1026706 powder for oral solution (PfOS) with 200 mL of water plus matching placebo to BI 1026706 PfOS (to have 80 mL volume in total) and a placebo film-coated tablet.
|
BI 200 mg PfOS
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of 200 mg of BI 1026706 powder for oral solution (PfOS) with 200 mL of water and a placebo film-coated tablet.
|
Placebo
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of matching placebo to BI 1026706 powder for oral solution with 200 mL of water and placebo film coated tablet.
|
Celecoxib 200 mg
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of Celecoxib hard capsule of 200 mg with 200 mL of water plus matching placebo to BI 1026706 PfOS.
|
|---|---|---|---|---|
|
Time to Meaningful Pain Relief
|
5.00 hours
Due to low number of events, 95% Confidence interval was not estimable thus not reported.
|
2.67 hours
Interval 2.67 to
Due to low number of events, Upper limit of the 95% Confidence interval was not estimable thus not reported.
|
NA hours
Due to only one event reported, Median and 95% Confidence interval was not estimable thus not reported.
|
1.93 hours
Interval 1.25 to 2.37
|
SECONDARY outcome
Timeframe: up to 10 hours post drug administrationPopulation: PD set
The time to first dose of rescue medication was defined by the difference in time of the study drug intake and the time of first rescue medication use within the first 10 h after study drug administration. Kaplan-Meier estimates over time for each treatment and time to event endpoint 'Time to first dose of rescue medication' were presented descriptively. Subjects without intake of rescue medication within the first 10 hours after study drug administration were censored at 10 hours.
Outcome measures
| Measure |
BI 50 mg PfOS
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of 50 mg of Boehringer Ingelheim (BI) 1026706 powder for oral solution (PfOS) with 200 mL of water plus matching placebo to BI 1026706 PfOS (to have 80 mL volume in total) and a placebo film-coated tablet.
|
BI 200 mg PfOS
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of 200 mg of BI 1026706 powder for oral solution (PfOS) with 200 mL of water and a placebo film-coated tablet.
|
Placebo
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of matching placebo to BI 1026706 powder for oral solution with 200 mL of water and placebo film coated tablet.
|
Celecoxib 200 mg
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of Celecoxib hard capsule of 200 mg with 200 mL of water plus matching placebo to BI 1026706 PfOS.
|
|---|---|---|---|---|
|
Time to First Dose of Rescue Medication
|
1.57 hours
Interval 1.1 to 2.27
|
1.53 hours
Interval 1.35 to 2.08
|
1.52 hours
Interval 1.17 to 1.58
|
NA hours
Interval 1.25 to
Due to low number of events, median and upper limit of the 95% Confidence interval was not estimable.
|
SECONDARY outcome
Timeframe: From first drug administration until 3 days after last drug administration, upto 4 daysPopulation: Treated Set
Percentage of patients with drug-related adverse events
Outcome measures
| Measure |
BI 50 mg PfOS
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of 50 mg of Boehringer Ingelheim (BI) 1026706 powder for oral solution (PfOS) with 200 mL of water plus matching placebo to BI 1026706 PfOS (to have 80 mL volume in total) and a placebo film-coated tablet.
|
BI 200 mg PfOS
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of 200 mg of BI 1026706 powder for oral solution (PfOS) with 200 mL of water and a placebo film-coated tablet.
|
Placebo
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of matching placebo to BI 1026706 powder for oral solution with 200 mL of water and placebo film coated tablet.
|
Celecoxib 200 mg
n=20 Participants
This trial has double dummy design, thus subjects were orally administered single dose of Celecoxib hard capsule of 200 mg with 200 mL of water plus matching placebo to BI 1026706 PfOS.
|
|---|---|---|---|---|
|
Percentage of Patients With Drug-related Adverse Events
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
Adverse Events
BI 50 mg PfOS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BI 200 mg PfOS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Celecoxib 200 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER