Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Smoking Cessation Study In Healthy Adolescent Smokers

12 de julho de 2018 atualizado por: Pfizer

A Twelve-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study With Follow-up Evaluating The Safety And Efficacy Of Varenicline For Smoking Cessation In Healthy Adolescent Smokers

The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

312

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Canadá
    • Ontario
      • Ajax, Ontario, Canadá, L1Z 0M1
        • Kids Clinic
      • New Market, Ontario, Canadá, L3Y 5G8
        • SKDS Research Inc.
      • Newmarket, Ontario, Canadá, L3Y 5G8
        • Private Practice of Robert J. Camargo
  • Estados Unidos
    • Alabama
      • Ozark, Alabama, Estados Unidos, 36360
        • IICR, Inc. (DBA: International Institute of Clinical Research)
    • Arizona
      • Goodyear, Arizona, Estados Unidos, 85395
        • Dedicated Clinical Research
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72211
        • Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
    • California
      • Anaheim, California, Estados Unidos, 92801
        • Anaheim Clinical Trials, LLC
      • La Habra, California, Estados Unidos, 90631
        • Omega Clinical Trials, LLC
      • National City, California, Estados Unidos, 91950
        • Synergy Clinical Research Center
      • Oakland, California, Estados Unidos, 94607
        • Pacific Research Partners, LLC
      • Oceanside, California, Estados Unidos, 92054
        • North County Clinical Research
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • University of Colorado Anschutz Medical Campus
      • Colorado Springs, Colorado, Estados Unidos, 80910
        • MCB Clinical Research Centers
      • Denver, Colorado, Estados Unidos, 80209
        • Western Affiliated Research Institute
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06520
        • Yale University
      • New Haven, Connecticut, Estados Unidos, 06511
        • Connecticut Mental Health Center
      • New Haven, Connecticut, Estados Unidos, 06511
        • Yale University, SATU
    • Florida
      • DeLand, Florida, Estados Unidos, 32720
        • Avail Clinical Research, LLC
      • Kissimmee, Florida, Estados Unidos, 34741
        • HOPE Clinical Research
      • Maitland, Florida, Estados Unidos, 32751
        • Florida Clinical Research Center, LLC
      • Miami, Florida, Estados Unidos, 33126
        • Pharmax Research Clinic, Inc.
      • Miami, Florida, Estados Unidos, 33144
        • L & L Research Choices
      • North Bay Village, Florida, Estados Unidos, 33141
        • Bravo Health Care Center
      • Orange City, Florida, Estados Unidos, 32763
        • Medical Research Group of Central Florida
      • Saint Petersburg, Florida, Estados Unidos, 33716
        • Comprehensive Clinical Development Inc.
    • Idaho
      • Meridian, Idaho, Estados Unidos, 83646
        • Solaris Clinical Research
      • Meridian, Idaho, Estados Unidos, 83646
        • Barney Greenspan, Ph.D
    • Indiana
      • Evansville, Indiana, Estados Unidos, 47715
        • Midwest Behavioral Health
      • Indianapolis, Indiana, Estados Unidos, 46260
        • Goldpoint Clinical Research, LLC
      • Newburgh, Indiana, Estados Unidos, 47630
        • Pedia Research, LLC
    • Kansas
      • Wichita, Kansas, Estados Unidos, 67207
        • Heartland Research Associates, LLC
    • Kentucky
      • Bardstown, Kentucky, Estados Unidos, 40004
        • Kentucky Pediatric/Adult Research
      • Lexington, Kentucky, Estados Unidos, 40509
        • Central Kentucky Research Associates, Inc.
      • Owensboro, Kentucky, Estados Unidos, 42301
        • Pedia Research, LLC
      • Owensboro, Kentucky, Estados Unidos, 42303
        • Research Integrity, LLC
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70114
        • Louisiana Research Associates, Inc
    • Massachusetts
      • Watertown, Massachusetts, Estados Unidos, 02472
        • Adams Clinical Trials, LLC
    • Michigan
      • Rochester Hills, Michigan, Estados Unidos, 48307
        • Rochester Center for Behavioral Medicine
    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64114
        • The Center for Pharmaceutical Research, P.C.
      • O'Fallon, Missouri, Estados Unidos, 63368
        • Psychiatric Care & Research Center
      • Saint Louis, Missouri, Estados Unidos, 63109
        • Mid-America Clinical Research, LLC
    • Nebraska
      • Lincoln, Nebraska, Estados Unidos, 68526
        • Premier Psychiatric Research Institute, LLC
    • North Carolina
      • Raleigh, North Carolina, Estados Unidos, 27612
        • Wake Research Associates
      • Raleigh, North Carolina, Estados Unidos, 27612
        • Wake Internal Medicine Consultants, Inc
      • Wilmington, North Carolina, Estados Unidos, 28401
        • PMG Research of Wilmington, LLC
    • Ohio
      • Canton, Ohio, Estados Unidos, 44718
        • Neuro-Behavioral Clinical Research, Inc.
      • Toledo, Ohio, Estados Unidos, 43623
        • Neurology & Neuroscience Center Of Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73116
        • Cutting Edge Research Group
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Medical University of South Carolina
      • Mount Pleasant, South Carolina, Estados Unidos, 29464
        • Coastal Carolina Research Center
    • Texas
      • Dallas, Texas, Estados Unidos, 75231
        • FutureSearch Trials of Dallas, L.P.
      • DeSoto, Texas, Estados Unidos, 75115
        • InSite Clinical Research, LLC
      • Lake Jackson, Texas, Estados Unidos, 77566
        • R/D Clinical Research, Inc.
      • San Antonio, Texas, Estados Unidos, 78229
        • Clinical Trials of Texas, Inc.
      • San Antonio, Texas, Estados Unidos, 78230
        • Thomas Murray DeMoor, MD
    • Virginia
      • Richmond, Virginia, Estados Unidos, 23235
        • Clinical Research Partners, LLC
    • Washington
      • Kirkland, Washington, Estados Unidos, 98033
        • Eastside Therapeutic Resource
      • Richland, Washington, Estados Unidos, 99352
        • Zain Research, Llc
    • Wisconsin
      • Middleton, Wisconsin, Estados Unidos, 53562
        • Dean Foundation for Health Research and Education
  • Federação Russa
      • Moscow, Federação Russa, 119331
        • GBUZ City childrens out-patient clinic # 10 of Moscow
      • Murmansk, Federação Russa, 183036
        • GOBUZ Murmansk Regional Narcology Dispensary
      • Novosibirsk, Federação Russa, 630091
        • LLC City Neurological Center "Sibneuromed"
      • Saint-Petersburg, Federação Russa, 190068
        • LLC " Alliance Biomedical - Russian Group"
      • Saint-Petersburg, Federação Russa, 191025
        • LLC Medical Technologies
      • Saint-Petersburg, Federação Russa, 192019
        • FSBI V.M.Bekhterev National Research Medical Center for Psychiatry and Neurology of RF MoH
      • Saint-Petersburg, Federação Russa, 192148
        • LLC Medical Technologies
      • Saint-Petersburg, Federação Russa, 197022
        • First St. Petersburg State Medical University
      • Samara, Federação Russa, 443031
        • GBUZ Samara Regional Childrens Health camp Yunost
    • Leningrad Region
      • Village Novoe Devyatkino, Leningrad Region, Federação Russa, 188661
        • Leningrad Regional Dispensary of Narcology
  • Geórgia
      • Rustavi, Geórgia, 3700
        • LTD" Rustavi Psychological Health Center"
  • Republica da Coréia
      • Daegu, Republica da Coréia, 41931
        • Keimyung University Dongsan Hospital
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Republica da Coréia, 14068
        • Hallym University Sacred Heart Hospital
      • Seongnam-si, Gyeonggi-do, Republica da Coréia, 13620
        • Seoul National University Bundang Hospital
      • Suwon-si, Gyeonggi-do, Republica da Coréia, 442 723
        • The Catholic University of Korea St. Vincent Hospital
  • Taiwan
      • Kaohsiung City, Taiwan, 81362
        • Kaohsiung Veterans General Hospital
      • New Taipei City, Taiwan, 220
        • Far Eastern Memorial Hospital
      • New Taipei City, Taiwan, 23561
        • Taipei Medical University Shuang Ho Hospital
      • Taichung city, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei City, Taiwan, 11217
        • Taipei Veterans General Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

12 anos a 19 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Healthy male and female subjects between the ages of 12 and 19, inclusive.
  • Subjects smoking at least an average of 5 cigarettes per day, motivated to stop smoking,
  • Subjects must have at least one prior failed attempt to quit smoking.

Exclusion Criteria:

  • Subjects with history, current diagnosis, or treatment of major depression disorder, anxiety disorders, panic disorder, hostility or aggression disorder, perceptual/thinking disturbances, mania, psychosis, bipolar disorder, personality disorder, eating disorder or severe emotional problems (in the past year).
  • Subjects with a prior suicide attempt: subjects hospitalized within the past 12 months due to suicidal ideation or suicidal behavior; subjects considered to have serious suicidal ideation or suicidal behavior in the past 12 months; active suicidal ideation or behavior identified at the screening or baseline visit.
  • Evidence of alcohol and substance abuse/dependence (other than nicotine) within 3 months prior to screening.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Varenicline 1mg BID
Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
Medicamento: Varenicline 1mg BID
Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
Experimental: Varenicline 0.5mg BID
Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
Medicamento: Varenicline 0.5mg BID
Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
Comparador de Placebo: Placebo
Oral placebo for twelve weeks,follow-up through Week 52
Medicamento: Placebo
Oral placebo for twelve weeks,follow-up through Week 52

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12
Prazo: Week 9 through Week 12
The percentage of participants who, at each visit from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and at each of these visits were confirmed to have quit based on urine cotinine less than 200 nanograms/milliliter (ng/mL).
Week 9 through Week 12

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52
Prazo: Weeks 12, 24 and 52
The percentage of participants who reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) on the Nicotine Use Inventory in the 7 days prior to the study visits or telephone contacts at Week 12,24 and 52.
Weeks 12, 24 and 52
Daily Number of Cigarettes Smoked at Baseline
Prazo: Baseline
The average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.
Baseline
Change From Baseline in Daily Number of Cigarettes Smoked at Weeks 12, 24, and 52
Prazo: Baseline, Weeks 12, 24, and 52
The reduction in the number of the cigarettes smoked was calculated by subtracting the reported average number of cigarettes smoked per day in the past 7 days at Weeks 12, 24 and 52 from the average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.
Baseline, Weeks 12, 24, and 52
Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 24 and Week 52
Prazo: Week 9 through Week 24; Week 9 through Week 52
The percentage of participants who, at each visit from Week 9 to 52 (inclusive), reported no smoking and no use of other nicotine-containing products (Weeks 9-12) or tobacco products (Weeks 13-52) since the last study visit/last contact (on the Nicotine Use Inventory) and at any of the study visits were confirmed to have quit based on urine cotinine less than 200 ng/mL.
Week 9 through Week 24; Week 9 through Week 52

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Prazo: First dose up to last dose (up-to Week 12) plus 30 days
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both non-serious AEs and SAEs.
First dose up to last dose (up-to Week 12) plus 30 days
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Prazo: First dose up to last dose (up-to Week 12) plus 30 days
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to drug Varenicline was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious AEs and SAEs.
First dose up to last dose (up-to Week 12) plus 30 days
Number of Participants With Treatment-Emergent Neuropsychiatric Adverse Event Elicited by Neuropsychiatric Adverse Event Interview (NAEI)
Prazo: First dose up to last dose (up-to Week 12) plus 30 days
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE: AE causing: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent/significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Solicited AEs collected by semi-structured NAEI inquiring about AEs: depression, anxiety, delusions, hallucinations, paranoia, psychosis, mania, panic, agitation, dissociative states, feeling abnormal, hostility, aggression and homicidal ideation. If a participant had a positive response to any item on the NAEI, investigator determined if it met criteria AE criteria.
First dose up to last dose (up-to Week 12) plus 30 days
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Prazo: Screening, Baseline, Week 1 up to Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (last follow-up [FU])
The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories);was an interview-based instrument to systematically assess suicidal ideation and suicidal behavior.C-SSRS assessed whether participant experienced any of the following:completed suicide;suicide attempt(response of "Yes" on "actual attempt");preparatory acts toward imminent suicidal behavior ("Yes" on "preparatory acts or behavior","aborted attempt" or "interrupted attempt"),suicidal ideation ("Yes" on "wish to be dead","non-specific active suicidal thoughts","active suicidal ideation with methods without intent to act or some intent to act,without specific plan or with specific plan and intent,any self-injurious behavior with no suicidal intent ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").Here,number of participants with positive response (response of "yes") to suicidal behavior or/and Ideation,any non-suicidal self-injurious behavior were reported.
Screening, Baseline, Week 1 up to Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (last follow-up [FU])
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety (HADS-A) Total Scores at Specified Time-points
Prazo: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
The HADS is a self-administered questionnaire measuring anxiety. Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A) consisted of 7 items that were assessed on a scale of 0 = no anxiety to 3 = severe feeling of anxiety. Total HADS-A subscale score range from 0 = no anxiety to 21 = severe anxiety; higher scores indicated more severe anxiety.
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores - Depression Total Score at Specified Time-Points
Prazo: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
Hospital Anxiety and Depression Scale Depression subscale (HADS-D) consists of 7 items that were assessed on a scale of 0 = no depression to 3 = severe feeling of depression. Total HADS-D subscale score range from 0 = no depression to 21 = severe feeling of depression; higher scores indicated a greater intensity of depression.
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
Number of Participants With Laboratory Abnormalities
Prazo: Baseline up to Week 12
Criteria for laboratory abnormalities: Lymphocytes Absolute (Abs), Lymphocytes percentage (%), Total Neutrophils (Abs), Neutrophils %: <0.8*LLN or >1.2*ULN; Basophils (Abs), Basophils %Eosinophils (Abs), Eosinophils %, Monocytes (Abs), Monocytes %:> 1.2*ULN; Total Bilirubin milligram per deciliter (mg/dl) >1.5*ULN; alanine aminotransferase: >3.0*ULN; Blood urea nitrogen, Creatinine: >1.3*ULN; Uric acid :> 1.2*ULN.
Baseline up to Week 12
Change From Baseline in Blood Pressure (BP) at Week 12
Prazo: Baseline, Week 12
Measurement of BP included supine and sitting systolic BP, standing systolic BP, supine and sitting diastolic BP and standing diastolic BP. Blood pressure was taken after participants rested in a sitting position for 5 minutes. BP was recorded after participants had been supine for approximately 5 minutes, and then orthostatic blood pressure was recorded immediately when the participant stood.
Baseline, Week 12
Change From Baseline in Pulse Rate at Week 12
Prazo: Baseline, Week 12
Measurement of pulse rate included supine, sitting and standing pulse rate. Pulse rate was taken after participants rested in a sitting position for 5 minutes. Pulse rate was recorded after participants had been supine for approximately 5 minutes and then immediately upon standing.
Baseline, Week 12

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Pfizer

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de abril de 2011

Conclusão Primária (Real)

1 de janeiro de 2018

Conclusão do estudo (Real)

1 de janeiro de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

9 de março de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de março de 2011

Primeira postagem (Estimativa)

11 de março de 2011

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de agosto de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de julho de 2018

Última verificação

1 de julho de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • A3051073
  • CHANTIX (Outro identificador: Alias Study Number)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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 Varenicline 1mg BID

Pesquisar ensaios semelhantes

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

CROs by country

CROs in Hong Kong

Condições

Doenças Raras

Intervenções de drogas

Suplementos Alimentares

Patrocinador / Colaboradores

Localizações

Se inscrever