- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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)
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
-
-
-
Verona, Itália
- 1320.13.39001 Boehringer Ingelheim Investigational Site
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: BI 1026706 low dose
|
Placebo to BI 1026706 solution
BI 1026706
Placebo to BI 1026706 tablet
|
|
Experimental: BI 1026706 high dose
|
BI 1026706
Placebo to BI 1026706 tablet
|
|
Experimental: Placebo reference
|
Placebo to BI 1026706 solution
Placebo to BI 1026706 tablet
|
|
Experimental: Celecoxib reference
Celecoxib capsule
|
Placebo to BI 1026706 solution
Celecoxib capsule
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
SPID0-8h
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
TOTPAR0-8h
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Processos Patológicos
- Complicações pós-operatórias
- Dor
- Manifestações Neurológicas
- Dor, Pós-operatório
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes do Sistema Nervoso Periférico
- Inibidores Enzimáticos
- Analgésicos
- Agentes do Sistema Sensorial
- Agentes anti-inflamatórios não esteróides
- Analgésicos, Não Narcóticos
- Antiinflamatórios
- Agentes Antirreumáticos
- Inibidores da Ciclooxigenase
- Inibidores da Ciclooxigenase 2
- Celecoxibe
Outros números de identificação do estudo
- 1320.13
- 2013-003580-62 (Número EudraCT: EudraCT)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .