Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Placebo to BI 1026706 solution; BI 1026706; Placebo to BI 1026706 tablet; Celecoxib
Intervention description: Placebo to BI 1026706 solution; BI 1026706; Placebo to BI 1026706 tablet; Celecoxib capsule
Intervention MeSH terms: Celecoxib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 80.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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)