このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Smoking Cessation Study In Healthy Adolescent Smokers

2018年7月12日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

312

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

12年～19年 (子、大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：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
薬：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
実験的：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
薬：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
プラセボコンパレーター：Placebo
Oral placebo for twelve weeks,follow-up through Week 52
薬：Placebo
Oral placebo for twelve weeks,follow-up through Week 52

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52
時間枠：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
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Number of Participants With Treatment-Emergent Adverse Events (AEs)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Pfizer

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2011年4月1日

一次修了 (実際)

2018年1月1日

研究の完了 (実際)

2018年1月1日

試験登録日

最初に提出

2011年3月9日

QC基準を満たした最初の提出物

2011年3月9日

最初の投稿 (見積もり)

2011年3月11日

学習記録の更新

投稿された最後の更新 (実際)

2018年8月9日

QC基準を満たした最後の更新が送信されました

2018年7月12日

最終確認日

2018年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • A3051073
  • CHANTIX (その他の識別子：Alias Study Number)

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Varenicline 1mg BIDの臨床試験

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Japan

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

購読する