- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03193450
Telephone-Based Re-education for Hp Eradication
Telephone-Based Re-Education of Drug Administration for Helicobacter Pylori Eradication: a Multi-Center Randomized, Controlled Study
It was suggested that the patient compliance plans an important role in the Hp eradication. However, data on whether re-education could improve the eradication rate are lacking. We consider that re-education on patients by telephone during the process of drug administration could increase the eradication rate in Hp infected patients.
We hypothesized that telephone re-education during the whole process of drug administration would improve the compliance of patients and ultimately increase the Hp eradication rate.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710061
- First Affiliated Hospital of Xi'an JiaoTong University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Prior informed consent
- 18-70 years of age
- Hp infected patients diagnosed by 13C urea breath test, including digestive ulcer, gastritis with dyspepsia symptoms, family history of gastric cancer, planning to use long-term non-steroidal anti-inflammatory drugs (NSAIDs), or personal request
- Ability to swallow oral medications
- No contraindication for the drugs used for Hp eradication
- Both men and women enrolled in this trial must use adequate barrier birth control during the course of the trial and 4 weeks after the completion of trial
Exclusion Criteria:
- Pregnant or breast-feeding subjects
- Previous failed treatment of Hp eradication
- Previous treatment with bismuth salts or antibiotics within 1 month before study enrollment, and treatment with proton pump inhibitor or H2 receptor antagonist within 2 weeks before study enrollment
- Any disease that could jeopardize the safety of subject and their compliance in the study (e.g. serious liver disease, heart disease, kidney disease, malignant tumor or alcoholism, etc.)
- Previous upper gastrointestinal surgery
- Inability to express complaint (e.g. mental disorder, psychoneurosis, unable to cooperation, etc.)
- Active clinically serious infections, except for Hepatitis B virus and hepatitis C virus infection
- Clinically significant gastrointestinal bleeding within 4 weeks prior to start of study drug
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Re-education group
Patients in this arm will receive a repeated instruction by telephone in terms of both calling and message at the forth, seventh, tenth day after the start of treatment.
|
Patients will receive a repeated instruction by telephone in terms of both calling and message at the forth, seventh, tenth day after the start of treatment.
Patients will receive an instruction card about the drug administration at the clinic by doctors.
|
Comparador Ativo: Non re-education group
Patients in this arm only received an instruction card about the drug administration at the clinic by doctors but no re-education by telephone during treatment
|
Patients will receive an instruction card about the drug administration at the clinic by doctors.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Hp eradication rate
Prazo: 4-6 weeks after the end of drug administration
|
Eradication rate is the proportion of patients with eradicated-Hp.
Hp infection was considered eradicated when negative results were obtained by 13carbon urea breath test at 4-6 weeks after the end of drug administration
|
4-6 weeks after the end of drug administration
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Symptoms relief rate
Prazo: 4-6 weeks after the end of drug administration
|
The symptoms were recorded according to Gastrointestinal Symptom Rating Scale.
|
4-6 weeks after the end of drug administration
|
Adverse events
Prazo: 4-6 weeks after the end of drug administration
|
The terms and grade of adverse events will be presented according to the Common Terminology Criteria for Adverse Events (CTCAE: version 4.0)
|
4-6 weeks after the end of drug administration
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Shuixiang He, MD, PhD, First Affiliated Hospital Xi'an Jiaotong University
Publicações e links úteis
Publicações Gerais
- Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988 Feb;33(2):129-34. doi: 10.1007/BF01535722.
- McColl KE. Clinical practice. Helicobacter pylori infection. N Engl J Med. 2010 Apr 29;362(17):1597-604. doi: 10.1056/NEJMcp1001110. No abstract available.
- Malfertheiner P, Sipponen P, Naumann M, Moayyedi P, Megraud F, Xiao SD, Sugano K, Nyren O; Lejondal H. pylori-Gastric Cancer Task Force. Helicobacter pylori eradication has the potential to prevent gastric cancer: a state-of-the-art critique. Am J Gastroenterol. 2005 Sep;100(9):2100-15. doi: 10.1111/j.1572-0241.2005.41688.x.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
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
Palavras-chave
Outros números de identificação do estudo
- XAJTU-DG001
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .
Ensaios clínicos em Infecção por Helicobacter Pylori
-
ImevaXConcluídoIndivíduos Infectados por Helicobacter Pylori | Indivíduos virgens de Helicobacter PyloriAlemanha
-
National Liver Institute, EgyptFuture pharmaceutical industriesRecrutamentoHelicobacter PyloriEgito
-
Hillel Yaffe Medical CenterAinda não está recrutando
-
Medical Research Council Unit, The GambiaNational Institute of Allergy and Infectious Diseases (NIAID)Concluído
-
Rabin Medical CenterDesconhecidoHelicobacter PyloriIsrael
-
TakedaConcluído
-
Fu Jen Catholic University HospitalAtivo, não recrutandoHelicobacter PyloriTaiwan
-
Poitiers University HospitalConcluído
-
Shandong UniversityDesconhecidoHelicobacter PyloriChina
-
TakedaConcluído