CompletedNCT02084511Updated Apr 12, 2019Results posted

Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain

A Phase 1 interventional study of Placebo to BI 1026706 solution and BI 1026706 in Pain, Postoperative, sponsored by Boehringer Ingelheim. Completed at 1 site in Italy. Open to male participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-04-12.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 80
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: Male

Study summary

To investigate the effectiveness of BI 1026706 powder for reconstitution of an oral solution compared to placebo and the relative effectiveness compared to Celecoxib.

Conditions studied

Pain, Postoperative

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Pain, Postoperative 5,224

In context

Pain, Postoperative

5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.

This study's enrollment of 80 is close to the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.

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Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.

Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.

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Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: Male
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure,Pulse Rate), 12-lead electrocardiogram, and clinical laboratory tests
Age 18 to 55 years (incl.)
Body Mass Index 18.5 to 29.9 kg/m2 (incl.)
Patients scheduled for removal of one mandibular third molar with partial or complete bony impaction. If medically indicated, the ipsilateral third molar in the upper jaw could also be removed;
Surgery will be conducted under local anaesthesia using 12% lidocaine (with epinephrine). Intravenous sedations and general anaesthetics are not permitted.
Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaire form
Examined by the attending oral surgeon or physician and medically cleared to participate in the study
Scheduled to undergo a qualifying surgical procedure
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria

Exclusion criteria:

Any finding in the medical examination (including Blod Pressure, Pulse Rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator
Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged clinically relevant by the investigator
Acute local infection at the time of surgery that could confound the post-surgical evaluation
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double
Enrollment: 80 participants (actual)

Study arms

Experimental
BI 1026706 low dose
BI 1026706 low dose
Drug: Placebo to BI 1026706 solution · Drug: BI 1026706 · Drug: Placebo to BI 1026706 tablet
Experimental
BI 1026706 high dose
BI 1026706 high dose
Drug: BI 1026706 · Drug: Placebo to BI 1026706 tablet
Experimental
Placebo reference
Placebo reference
Drug: Placebo to BI 1026706 solution · Drug: Placebo to BI 1026706 tablet
Experimental
Celecoxib reference
Celecoxib capsule
Drug: Placebo to BI 1026706 solution · Drug: Celecoxib

Interventions

DrugPlacebo to BI 1026706 solution
Placebo to BI 1026706 solution
DrugBI 1026706
BI 1026706
DrugPlacebo to BI 1026706 tablet
Placebo to BI 1026706 tablet
DrugCelecoxib
Celecoxib capsule

What researchers measure

Primary outcomes

SPID0-8h
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.
Time frame: up to 8 hours post drug administration

Secondary outcomes

TOTPAR0-8h
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.
Time frame: up to 8 hours post drug administration
SPID0-2h
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.
Time frame: up to 2 hours post drug administration
Time to Meaningful Pain Relief
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.
Time frame: up to 10 hours post drug administration
Time to First Dose of Rescue Medication
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.
Time frame: up to 10 hours post drug administration
Percentage of Patients With Drug-related Adverse Events
Percentage of patients with drug-related adverse events
Time frame: From first drug administration until 3 days after last drug administration, upto 4 days

Results

Posted Apr 12, 2019

Participant flow

Participant flow — Overall Study
Milestone	BI 50 mg PfOS	BI 200 mg PfOS	Placebo	Celecoxib 200 mg
Started	20	20	20	20
Completed	20	20	20	20
Not completed	0	0	0	0

Outcome measures

PrimarySPID0-8h

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.

Time frame:: up to 8 hours post drug administration
Reported as:: Least squares mean · units on scale

SPID0-8h
units on scale	BI 50 mg PfOS	BI 200 mg PfOS	Placebo	Celecoxib 200 mg
SPID0-8h	-50.14 (-123.5 to 23.2)	-24.06 (-97.4 to 49.3)	-77.54 (-150.9 to -4.2)	124.47 (51.1 to 197.8)

Statistical analysis

BI 50 mg PfOS vs Placebo · Mean difference (final values): 27.39 · 95% CI -76.3 to 131.1Mean difference (final values) is actually the Least square mean
BI 200 mg PfOS vs Placebo · Mean difference (final values): 53.48 · 95% CI -50.2 to 157.1Mean difference (final values) is actually the Least square mean
BI 50 mg PfOS vs Celecoxib 200 mg · Mean difference (final values): -174.61 · 95% CI -278.3 to -70.9Mean difference (final values) is actually the Least square mean
BI 200 mg PfOS vs Celecoxib 200 mg · Mean difference (final values): -148.53 · 95% CI -252.4 to -44.7Mean difference (final values) is actually the Least square mean

SecondaryTOTPAR0-8h

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.

Time frame:: up to 8 hours post drug administration
Reported as:: Least squares mean · units on scale

TOTPAR0-8h
units on scale	BI 50 mg PfOS	BI 200 mg PfOS	Placebo	Celecoxib 200 mg
TOTPAR0-8h	3.85 (1.0 to 6.7)	3.14 (0.3 to 6.0)	2.16 (-0.7 to 5.0)	10.12 (7.3 to 13.0)

Statistical analysis

BI 50 mg PfOS vs Placebo · Mean difference (final values): 1.70 · 95% CI -2.3 to 5.7Mean difference (final values) is actually the Least square mean
BI 200 mg PfOS vs Placebo · Median difference (final values): 0.98 · 95% CI -3.0 to 5.0Mean difference (final values) is actually the Least square mean
BI 50 mg PfOS vs Celecoxib 200 mg · Mean difference (final values): -6.27 · 95% CI -10.3 to -2.2Mean difference (final values) is actually the Least square mean
BI 200 mg PfOS vs Celecoxib 200 mg · Mean difference (final values): -6.98 · 95% CI -11.0 to -2.9Mean difference (final values) is actually the Least square mean

SecondarySPID0-2h

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.

Time frame:: up to 2 hours post drug administration
Reported as:: Least squares mean · units on scale

SPID0-2h
units on scale	BI 50 mg PfOS	BI 200 mg PfOS	Placebo	Celecoxib 200 mg
SPID0-2h	-8.08 (-23.6 to 7.4)	6.57 (-8.9 to 22.1)	-14.01 (-29.5 to 1.5)	5.20 (-10.3 to 20.7)

Statistical analysis

BI 50 mg PfOS vs Placebo · Mean difference (final values): 5.93 · 95% CI -16.0 to 27.8Mean difference (final values) is actually the Least square mean
BI 200 mg PfOS vs Placebo · Mean difference (final values): 20.58 · 95% CI -1.3 to 42.5Mean difference (final values) is actually the Least square mean
BI 50 mg PfOS vs Celecoxib 200 mg · Mean difference (final values): -13.29 · 95% CI -35.2 to 8.6Mean difference (final values) is actually the Least square mean
BI 200 mg PfOS vs Celecoxib 200 mg · Mean difference (final values): 1.37 · 95% CI -20.6 to 23.3Mean difference (final values) is actually the Least square mean

SecondaryTime to Meaningful Pain Relief

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.

Time frame:: up to 10 hours post drug administration
Reported as:: Median · hours

Time to Meaningful Pain Relief
hours	BI 50 mg PfOS	BI 200 mg PfOS	Placebo	Celecoxib 200 mg
Time to Meaningful Pain Relief	5.00 (NA to NA)	2.67 (2.67 to NA)	NA (NA to NA)	1.93 (1.25 to 2.37)

Statistical analysis

BI 50 mg PfOS vs Placebo · Log Rank · p = 0.2503
BI 200 mg PfOS vs Placebo · Log Rank · p = 0.1851
Placebo vs Celecoxib 200 mg · Log Rank · p = 0.0167

SecondaryTime to First Dose of Rescue Medication

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.

Time frame:: up to 10 hours post drug administration
Reported as:: Median · hours

Time to First Dose of Rescue Medication
hours	BI 50 mg PfOS	BI 200 mg PfOS	Placebo	Celecoxib 200 mg
Time to First Dose of Rescue Medication	1.57 (1.10 to 2.27)	1.53 (1.35 to 2.08)	1.52 (1.17 to 1.58)	NA (1.25 to NA)

Statistical analysis

BI 50 mg PfOS vs Placebo · Log Rank · p = 0.4150
BI 200 mg PfOS vs Placebo · Log Rank · p = 0.3093
Placebo vs Celecoxib 200 mg · Log Rank · p = 0.0074

SecondaryPercentage of Patients With Drug-related Adverse Events

Percentage of patients with drug-related adverse events

Time frame:: From first drug administration until 3 days after last drug administration, upto 4 days
Reported as:: Number · Percentage of participants

Percentage of Patients With Drug-related Adverse Events
Percentage of participants	BI 50 mg PfOS	BI 200 mg PfOS	Placebo	Celecoxib 200 mg
Percentage of Patients With Drug-related Adverse Events	0.0	0.0	0.0	0.0

Adverse events

Collected over From first drug administration until 3 days after last drug administration, upto 4 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
BI 50 mg PfOS	—	0/20 (0%)	0/20 (0%)
BI 200 mg PfOS	—	0/20 (0%)	0/20 (0%)
Placebo	—	0/20 (0%)	0/20 (0%)
Celecoxib 200 mg	—	0/20 (0%)	0/20 (0%)

Baseline characteristics

Treated set: The treated set (TS) included all randomised patients who received study medication.

Age, Continuous
Age, Continuous(Years)	BI 50 mg PfOS	BI 200 mg PfOS	Placebo	Celecoxib 200 mg	Total
Mean	27.0 ± 8.7	24.2 ± 6.0	26.9 ± 5.7	26.5 ± 7.8	26.1 ± 7.1

Sex: Female, Male
Sex: Female, Male(Participants)	BI 50 mg PfOS	BI 200 mg PfOS	Placebo	Celecoxib 200 mg	Total
Female	0	0	0	0	0
Male	20	20	20	20	80

Study locations

1 site

1320.13.39001 Boehringer Ingelheim Investigational Site
Verona, Italy

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02084511
Lead sponsor: Boehringer Ingelheim
Responsible party: Sponsor
First posted: Mar 12, 2014
Start date: Mar 2014
Primary completion: Oct 2014
Completion: Oct 2014
Results posted: Apr 12, 2019
Last update: Apr 12, 2019

Study contacts

Boehringer Ingelheim

study chair · Boehringer Ingelheim

View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: BI 1026706 · Celecoxib

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Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain

Study summary

Conditions studied

Browse trials for

In context

Pain, Postoperative

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

Updates

Registry details

Key details

Study contacts

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria