Clinical trial NCT02084511: Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain, Postoperative
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-03-12
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Primary outcomes:
measure: SPID0-8h
timeFrame: up to 8 hours post drug administration
Secondary outcomes:
measure: TOTPAR0-8h
timeFrame: up to 8 hours post drug administration
measure: SPID0-2h
timeFrame: up to 2 hours post drug administration
measure: Time to Meaningful Pain Relief
timeFrame: up to 10 hours post drug administration
measure: Time to First Dose of Rescue Medication
timeFrame: up to 10 hours post drug administration
measure: Percentage of Patients With Drug-related Adverse Events
timeFrame: From first drug administration until 3 days after last drug administration, upto 4 days
Other outcomes:
Locations:
city: Verona
country: Italy
facility: 1320.13.39001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: