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

10. april 2019 oppdatert av: Boehringer Ingelheim

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)

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

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

80

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Verona, Italia
        • 1320.13.39001 Boehringer Ingelheim Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 55 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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
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
From first drug administration until 3 days after last drug administration, upto 4 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

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Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2014

Primær fullføring (Faktiske)

1. oktober 2014

Studiet fullført (Faktiske)

1. oktober 2014

Datoer for studieregistrering

Først innsendt

10. mars 2014

Først innsendt som oppfylte QC-kriteriene

10. mars 2014

Først lagt ut (Anslag)

12. mars 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. april 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. april 2019

Sist bekreftet

1. april 2019

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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