- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
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Verona, Italia
- 1320.13.39001 Boehringer Ingelheim Investigational Site
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: BI 1026706 low dose
|
Placebo to BI 1026706 solution
BI 1026706
Placebo to BI 1026706 tablet
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|
Sperimentale: BI 1026706 high dose
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BI 1026706
Placebo to BI 1026706 tablet
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Sperimentale: Placebo reference
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Placebo to BI 1026706 solution
Placebo to BI 1026706 tablet
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|
Sperimentale: Celecoxib reference
Celecoxib capsule
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Placebo to BI 1026706 solution
Celecoxib capsule
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
SPID0-8h
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
TOTPAR0-8h
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: up to 10 hours post drug administration
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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
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Percentage of Patients With Drug-related Adverse Events
Lasso di tempo: From first drug administration until 3 days after last drug administration, upto 4 days
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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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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Complicanze postoperatorie
- Dolore
- Manifestazioni neurologiche
- Dolore, Postoperatorio
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti del sistema nervoso periferico
- Inibitori enzimatici
- Analgesici
- Agenti del sistema sensoriale
- Agenti antinfiammatori, non steroidei
- Analgesici, non narcotici
- Agenti antinfiammatori
- Agenti antireumatici
- Inibitori della ciclossigenasi
- Inibitori della cicloossigenasi 2
- Celecoxib
Altri numeri di identificazione dello studio
- 1320.13
- 2013-003580-62 (Numero EudraCT: EudraCT)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .