- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02084511
Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain
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)
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
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Verona, Italia
- 1320.13.39001 Boehringer Ingelheim Investigational Site
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: BI 1026706 low dose
|
Placebo to BI 1026706 solution
BI 1026706
Placebo to BI 1026706 tablet
|
|
Eksperimentell: BI 1026706 high dose
|
BI 1026706
Placebo to BI 1026706 tablet
|
|
Eksperimentell: Placebo reference
|
Placebo to BI 1026706 solution
Placebo to BI 1026706 tablet
|
|
Eksperimentell: Celecoxib reference
Celecoxib capsule
|
Placebo to BI 1026706 solution
Celecoxib capsule
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
SPID0-8h
Tidsramme: 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.
|
up to 8 hours post drug administration
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
TOTPAR0-8h
Tidsramme: up to 8 hours post drug administration
|
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.
|
up to 8 hours post drug administration
|
|
SPID0-2h
Tidsramme: up to 2 hours post drug administration
|
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.
|
up to 2 hours post drug administration
|
|
Time to Meaningful Pain Relief
Tidsramme: up to 10 hours post drug administration
|
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. |
up to 10 hours post drug administration
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Time to First Dose of Rescue Medication
Tidsramme: up to 10 hours post drug administration
|
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. |
up to 10 hours post drug administration
|
|
Percentage of Patients With Drug-related Adverse Events
Tidsramme: From first drug administration until 3 days after last drug administration, upto 4 days
|
Percentage of patients with drug-related adverse events
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From first drug administration until 3 days after last drug administration, upto 4 days
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Postoperative komplikasjoner
- Smerte
- Nevrologiske manifestasjoner
- Smerter, postoperativt
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystemet
- Enzymhemmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirevmatiske midler
- Syklooksygenase-hemmere
- Syklooksygenase 2-hemmere
- Celecoxib
Andre studie-ID-numre
- 1320.13
- 2013-003580-62 (EudraCT-nummer: EudraCT)
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