Pain, PostoperativePhase 1NCT02084511

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

A Phase 1 study testing BI 1026706 and Celecoxib in people with Pain, Postoperative, run by Boehringer Ingelheim at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 years, men only
Conditions the study is for: Pain, Postoperative
What is being tested?: BI 1026706 and Celecoxib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteItaly
Study dates: Mar 2014to Oct 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
No healthy volunteers
Adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Italy1 site

1320.13.39001 Boehringer Ingelheim Investigational Site
Verona

Other trials in Italy

About this study

Official title: Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain (a Single-centre, Partially Double-blinded, Randomised, placebo-and Active Comparator-controlled, Single-dose, Parallel-group Study)

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: Pain, Postoperative
Being tested: Placebo to BI 1026706 solution, BI 1026706, Placebo to BI 1026706 tablet, Celecoxib
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo to BI 1026706 solutionDrug
Placebo to BI 1026706 solution
BI 1026706Drug
BI 1026706
Placebo to BI 1026706 tabletDrug
Placebo to BI 1026706 tablet
CelecoxibDrug
Celecoxib capsule

Study groups in NCT02084511
Study group	Role	What they receive
BI 1026706 low dose	Experimental	BI 1026706 low dose Receives: Drug: Placebo to BI 1026706 solution; Drug: BI 1026706; Drug: Placebo to BI 1026706 tablet
BI 1026706 high dose	Experimental	BI 1026706 high dose Receives: Drug: BI 1026706; Drug: Placebo to BI 1026706 tablet
Placebo reference	Experimental	Placebo reference Receives: Drug: Placebo to BI 1026706 solution; Drug: Placebo to BI 1026706 tablet
Celecoxib reference	Experimental	Celecoxib capsule Receives: Drug: Placebo to BI 1026706 solution; Drug: Celecoxib

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: up to 8 hours post drug administration

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 10 hours post drug administration
Percentage of Patients With Drug-related Adverse Events
Percentage of patients with drug-related adverse events
Measured: From first drug administration until 3 days after last drug administration, upto 4 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Oct 2014

First posted12 Mar 2014 (estimated)
Study startMar 2014
Primary completionOct 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02084511
Sponsor's protocol ID: 1320.13
Other IDs: 2013-003580-62
Status last verified: Apr 2019
First submitted: 10 Mar 2014
Last updated: 12 Apr 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section

All Pain, Postoperative trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain (a Single-centre, Partially Double-blinded, Randomised, placebo-and Active Comparator-controlled, Single-dose, Parallel-group Study)
ClinicalTrials.gov ID: NCT02084511
Acronym / sponsor ID: 1320.13
Conditions: Pain, Postoperative
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 12 Mar 2014 (estimated)
Results: Posted 12 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 4

Arm	Type	Receives
BI 1026706 low dose	Experimental	Drug: Placebo to BI 1026706 solution, Drug: BI 1026706, Drug: Placebo to BI 1026706 tabletBI 1026706 low dose
BI 1026706 high dose	Experimental	Drug: BI 1026706, Drug: Placebo to BI 1026706 tabletBI 1026706 high dose
Placebo reference	Experimental	Drug: Placebo to BI 1026706 solution, Drug: Placebo to BI 1026706 tabletPlacebo reference
Celecoxib reference	Experimental	Drug: Placebo to BI 1026706 solution, Drug: CelecoxibCelecoxib capsule

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo to BI 1026706 solutionPlacebo to BI 1026706 solution	Drug	BI 1026706 low dose, Celecoxib reference, Placebo reference
BI 1026706BI 1026706	Drug	BI 1026706 high dose, BI 1026706 low dose
Placebo to BI 1026706 tabletPlacebo to BI 1026706 tablet	Drug	BI 1026706 high dose, BI 1026706 low dose, Placebo reference
CelecoxibCelecoxib capsule	Drug	Celecoxib reference

Primary outcome

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

5 secondary outcomes

TOTPAR0-8h
Time frame: up to 8 hours post drug administration
SPID0-2h
Time frame: up to 2 hours post drug administration
Time to Meaningful Pain Relief
Time frame: up to 10 hours post drug administration
Time to First Dose of Rescue Medication
Time frame: up to 10 hours post drug administration
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 and safety

Results posted to the registry on 12 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BI 50 mg PfOS	20	20
BI 200 mg PfOS	20	20
Placebo	20	20
Celecoxib 200 mg	20	20

Primary outcome: SPID0-8h

Time frame: up to 8 hours post drug administration. Least squares mean (95% Confidence Interval). Unit: units on scale

Measure	BI 50 mg PfOS n = 20	BI 200 mg PfOS n = 20	Placebo n = 20	Celecoxib 200 mg n = 20
Value	-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)

BI 50 mg PfOS vs Placebo: Mean Difference (Final Values): 27.39 (95% CI -76.3 to 131.1)
BI 200 mg PfOS vs Placebo: Mean Difference (Final Values): 53.48 (95% CI -50.2 to 157.1)
BI 50 mg PfOS vs Celecoxib 200 mg: Mean Difference (Final Values): -174.61 (95% CI -278.3 to -70.9)

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 3 days after last drug administration, upto 4 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 50 mg PfOS	0 of 20 (0%)	0 of 20 (0%)	Not reported
BI 200 mg PfOS	0 of 20 (0%)	0 of 20 (0%)	Not reported
Placebo	0 of 20 (0%)	0 of 20 (0%)	Not reported
Celecoxib 200 mg	0 of 20 (0%)	0 of 20 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pain, Postoperative

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 1026706 and Celecoxib in people with Pain, Postoperative, run by Boehringer Ingelheim at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SPID0-8h (time frame: up to 8 hours post drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02084511.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.