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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Pain, Postoperative

Treatments: Drug: BI 1026706; Drug: Celecoxib; Drug: Placebo to BI 1026706 solution; Drug: Placebo to BI 1026706 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02084511

1320.13

2013-003580-62 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. Age 18 to 55 years (incl.)
3. Body Mass Index 18.5 to 29.9 kg/m2 (incl.)
4. 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;
5. Surgery will be conducted under local anaesthesia using 12% lidocaine (with epinephrine). Intravenous sedations and general anaesthetics are not permitted.
6. Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaire form
7. Examined by the attending oral surgeon or physician and medically cleared to participate in the study
8. Scheduled to undergo a qualifying surgical procedure
9. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups

BI 1026706 low dose

Experimental group

Description:

BI 1026706 low dose

Treatment:

Drug: Placebo to BI 1026706 tablet

Drug: Placebo to BI 1026706 solution

Drug: BI 1026706

BI 1026706 high dose

Experimental group

Description:

BI 1026706 high dose

Treatment:

Drug: Placebo to BI 1026706 tablet

Drug: BI 1026706

Placebo reference

Experimental group

Description:

Placebo reference

Treatment:

Drug: Placebo to BI 1026706 tablet

Drug: Placebo to BI 1026706 solution

Celecoxib reference

Experimental group

Description:

Celecoxib capsule

Treatment:

Drug: Celecoxib

Drug: Placebo to BI 1026706 solution