Phase 1
N=80
Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT02084511 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: SPID0-8h — -50.14; -24.06; -77.54; 124.47 units on scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Placebo to BI 1026706 solution (Drug); BI 1026706 (Drug); Placebo to BI 1026706 tablet (Drug); Celecoxib (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SPID0-8h |
-50.14; -24.06; -77.54; 124.47 | — |
| SECONDARY TOTPAR0-8h |
3.85; 3.14; 2.16; 10.12 | — |
| SECONDARY SPID0-2h |
-8.08; 6.57; -14.01; 5.20 | — |
| SECONDARY Time to Meaningful Pain Relief |
5.00; 2.67; NA; 1.93 | 0.2503 |
| SECONDARY Time to First Dose of Rescue Medication |
1.57; 1.53; 1.52; NA | 0.4150 |
| SECONDARY Percentage of Patients With Drug-related Adverse Events |
0.0; 0.0; 0.0; 0.0 | — |
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
- 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
- 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)
Data sourced from ClinicalTrials.gov (NCT02084511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.