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临床试验/NCT02355665
NCT02355665已完成3 期

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study Using a Naturalistic Clinical Model to Measure the Efficacy and Safety of a Novel Nicotine Replacement Therapy in Smokers Motivated to Quit

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.6 个研究点 分布在 1 个国家目标入组 1,198 人开始时间: 2015年1月31日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
1,198
试验地点
6
主要终点
Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the efficacy and safety of a novel nicotine product for continuous abstinence from smoking. Efficacy of product will be evaluated by assessments of self-reported abstinence, verified by exhaled carbon monoxide (CO) levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Subjects must be males or females 18-85 years of age who currently smoke cigarettes daily and are willing to stop smoking

排除标准

  • •History of cardiovascular disease, stomach ulcer or diabetes unless physician's written approval is obtained.
  • •Use of other forms of tobacco/nicotine containing products other than cigarettes within 30 days before baseline visit.
  • •Use of nicotine replacement therapies or other smoking cessation medicines/non-drug therapies within 30 days before the baseline visit.
  • •Pregnancy or intending to become pregnant.
  • •Hypersensitivity to the product, history of alcohol or substance abuse.

研究组 & 干预措施

Nicotine

Experimental

Nicotine Spray

干预措施: Nicotine Spray (Drug)

Placebo

Placebo Comparator

Placebo to match Nicotine spray

干预措施: Placebo (Drug)

结局指标

主要结局

Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6

时间窗: Week 2 to Week 6

Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking

次要结局

  • Pulse at Week 4(Week 4)
  • Pulse at Week 16(Week 16)
  • Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12(Week 2 to Week 12)
  • Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 26(Week 2 to Week 26)
  • Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6(Week 6)
  • Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 4(Week 2 to Week 4)
  • Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 16(Week 2 to Week 16)
  • Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2(Week 2)
  • Total Daily Number of Self-Reported Spray Doses at Week 13(Week 13)
  • Total Daily Number of Self-Reported Spray Doses at Week 15(Week 15)
  • Total Daily Number of Self-Reported Spray Doses at Week 20(Week 20)
  • Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1(Week 1)
  • Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4(Week 4)
  • Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6(Week 6)
  • Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1(Week 1)
  • Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2(Week 2)
  • Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 20(Week 2 to Week 20)
  • Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2(Week 2)
  • Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1(Week 1)
  • Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1(Week 1)
  • Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4(Week 4)
  • Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4(Week 4)
  • Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6(Week 6)
  • Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2(Week 2)
  • Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4(Week 4)
  • Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 8(Week 2 to Week 8)
  • Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2(Week 2)
  • Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4(Week 4)
  • Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6(Week 6)
  • Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1(Week 1)
  • Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1(Week 1)
  • Total Daily Number of Self-Reported Spray Doses at Week 1(Week 1)
  • Total Daily Number of Self-Reported Spray Doses at Week 5(Week 5)
  • Total Daily Number of Self-Reported Spray Doses at Week 6(Week 6)
  • Total Daily Number of Self-Reported Spray Doses at Week 9(Week 9)
  • Total Daily Number of Self-Reported Spray Doses at Week 12(Week 12)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 6(Week 6)
  • Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2(Week 2)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 7(Week 7)
  • Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4(Week 4)
  • Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1(Week 1)
  • Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4(Week 4)
  • Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6(Week 6)
  • Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6(Week 6)
  • Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1(Week 1)
  • Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4(Week 4)
  • Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6(Week 6)
  • Aggregated Withdrawal Score at Week 4(Week 4)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 10(Week 10)
  • Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2(Week 2)
  • Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2(Week 2)
  • Aggregated Withdrawal Score at Week 1(Week 1)
  • Total Daily Number of Self-Reported Spray Doses at Week 7(Week 7)
  • Total Daily Number of Self-Reported Spray Doses at Week 17(Week 17)
  • Total Daily Number of Self-Reported Spray Doses at Week 18(Week 18)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 3(Week 3)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 5(Week 5)
  • Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6(Week 6)
  • Aggregated Withdrawal Score at Week 2(Week 2)
  • Total Daily Number of Self-Reported Spray Doses at Week 3(Week 3)
  • Total Daily Number of Self-Reported Spray Doses at Week 4(Week 4)
  • Total Daily Number of Self-Reported Spray Doses at Week 8(Week 8)
  • Total Daily Number of Self-Reported Spray Doses at Week 10(Week 10)
  • Total Daily Number of Self-Reported Spray Doses at Week 16(Week 16)
  • Total Daily Number of Self-Reported Spray Doses at Week 19(Week 19)
  • Total Daily Number of Self-Reported Spray Doses at Week 21(Week 21)
  • Total Daily Number of Self-Reported Spray Doses at Week 22(Week 22)
  • Total Daily Number of Self-Reported Spray Doses at Week 24(Week 24)
  • Total Daily Number of Self-Reported Spray Doses at Week 25(Week 25)
  • Total Daily Number of Self-Reported Spray Doses at Week 26(Week 26)
  • Aggregated Withdrawal Score at Week 6(Week 6)
  • Total Daily Number of Self-Reported Spray Doses at Week 2(Week 2)
  • Total Daily Number of Self-Reported Spray Doses at Week 11(Week 11)
  • Total Daily Number of Self-Reported Spray Doses at Week 14(Week 14)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 11(Week 11)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 16(Week 16)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 17(Week 17)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 19(Week 19)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 20(Week 20)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 1(Week 1)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 5(Week 5)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 11(Week 11)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 15(Week 15)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 16(Week 16)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 15(Week 15)
  • Total Daily Number of Self-Reported Spray Doses at Week 23(Week 23)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 1(Week 1)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 2(Week 2)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 9(Week 9)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 12(Week 12)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 14(Week 14)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 23(Week 23)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 3(Week 3)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 6(Week 6)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 7(Week 7)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 12(Week 12)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 13(Week 13)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 21(Week 21)
  • Number of Cigarettes Smoked Since Last Visit at Week 2(Week 2)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 8(Week 8)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 13(Week 13)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 18(Week 18)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 14(Week 14)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 23(Week 23)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 24(Week 24)
  • Number of Cigarettes Smoked Per Day at Week 16(Week 16)
  • Number of Cigarettes Smoked Per Day at Week 26(Week 26)
  • Percentage Distribution of the Participant Score for Overall Product Rating at Week 1(Week 1)
  • Change From Baseline in Systolic Blood Pressure at Week 4(Baseline to Week 4)
  • Change From Baseline in Systolic Blood Pressure at Week 12(Baseline to Week 12)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 4(Week 4)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 21(Week 21)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 24(Week 24)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 26(Week 26)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 4(Week 4)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 8(Week 8)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 9(Week 9)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 10(Week 10)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 17(Week 17)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 19(Week 19)
  • Number of Cigarettes Smoked Since Last Visit at Week 1(Week 1)
  • Number of Cigarettes Smoked Per Day at Week 4(Week 4)
  • Change From Baseline in Systolic Blood Pressure at Week 26(Baseline to Week 26)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 18(Week 18)
  • Diastolic Blood Pressure at Week 6(Week 6)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 20(Week 20)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 22(Week 22)
  • Maximum Total Daily Number of Self-Reported Spray Doses at Week 25(Week 25)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 2(Week 2)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 26(Week 26)
  • Number of Cigarettes Smoked Per Day at Week 6(Week 6)
  • Number of Cigarettes Smoked Per Day at Week 8(Week 8)
  • Number of Cigarettes Smoked Per Day at Week 12(Week 12)
  • Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6(Week 6)
  • Systolic Blood Pressure at Week 6(Week 6)
  • Systolic Blood Pressure at Week 8(Week 8)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 22(Week 22)
  • Maximum Hourly Number of Self-Reported Spray Doses at Week 25(Week 25)
  • Percentage Distribution of the Participant Score for Overall Product Rating at Week 12(Week 12)
  • Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12(Week 12)
  • Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product(Week 1)
  • Systolic Blood Pressure at Week 26(Week 26)
  • Number of Cigarettes Smoked Per Day at Week 20(Week 20)
  • Percentage Distribution of the Participant Score for Overall Product Rating at Week 6(Week 6)
  • Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1(Week 1)
  • Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12(Week 12)
  • Systolic Blood Pressure at Week 1(Week 1)
  • Systolic Blood Pressure at Week 20(Week 20)
  • Change From Baseline in Diastolic Blood Pressure at Week 26(Baseline to Week 26)
  • Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6(Week 6)
  • Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1(Week 1)
  • Percentage Distribution of the Participant Score for Product Convenience at Week 6(Week 6)
  • Change From Baseline in Systolic Blood Pressure at Week 1(Baseline to Week 1)
  • Change From Baseline in Systolic Blood Pressure at Week 6(Baseline to Week 6)
  • Change From Baseline in Pulse at Week 2(Baseline to Week 2)
  • Pulse at Week 2(Week 2)
  • Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product(Week 6)
  • Systolic Blood Pressure at Week 2(Week 2)
  • Change From Baseline in Systolic Blood Pressure at Week 8(Baseline to Week 8)
  • Change From Baseline in Systolic Blood Pressure at Week 20(Baseline to Week 20)
  • Diastolic Blood Pressure at Week 1(Week 1)
  • Diastolic Blood Pressure at Week 2(Week 2)
  • Pulse at Week 20(Week 20)
  • Percentage of Participants With New or Worsened Conditions in Tongue at Week 6 or When Withdrawn From Study(Week 6 or when withdrawn from study)
  • Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product(Week 12)
  • Percentage Distribution of the Participant Score for Product Convenience at Week 1(Week 1)
  • Percentage Distribution of the Participant Score for Product Convenience at Week 12(Week 12)
  • Systolic Blood Pressure at Week 4(Week 4)
  • Systolic Blood Pressure at Week 12(Week 12)
  • Systolic Blood Pressure at Week 16(Week 16)
  • Diastolic Blood Pressure at Week 16(Week 16)
  • Change From Baseline in Diastolic Blood Pressure at Week 6(Baseline to Week 6)
  • Change From Baseline in Diastolic Blood Pressure at Week 12(Baseline to Week 12)
  • Change From Baseline in Pulse at Week 1(Baseline to Week 1)
  • Change From Baseline in Pulse at Week 8(Baseline to Week 8)
  • Change From Baseline in Systolic Blood Pressure at Week 2(Baseline to Week 2)
  • Change From Baseline in Systolic Blood Pressure at Week 16(Baseline to Week 16)
  • Diastolic Blood Pressure at Week 12(Week 12)
  • Diastolic Blood Pressure at Week 20(Week 20)
  • Change From Baseline in Diastolic Blood Pressure at Week 4(Baseline to Week 4)
  • Pulse at Week 8(Week 8)
  • Pulse at Week 12(Week 12)
  • Change From Baseline in Pulse at Week 12(Baseline to Week 12)
  • Change From Baseline in Pulse at Week 26(Baseline to Week 26)
  • Percentage of Participants With New or Worsened Conditions in Buccal Mucosa at Week 6 or When Withdrawn From Study(Week 6 or when withdrawn from study)
  • Percentage of Participants With New or Worsened Conditions in Sublingual Mucosa at Week 6 or When Withdrawn From Study(Week 6 or when withdrawn from study)
  • Diastolic Blood Pressure at Week 4(Week 4)
  • Diastolic Blood Pressure at Week 8(Week 8)
  • Diastolic Blood Pressure at Week 26(Week 26)
  • Change From Baseline in Diastolic Blood Pressure at Week 1(Baseline to Week 1)
  • Change From Baseline in Diastolic Blood Pressure at Week 2(Baseline to Week 2)
  • Change From Baseline in Diastolic Blood Pressure at Week 8(Baseline to Week 8)
  • Change From Baseline in Diastolic Blood Pressure at Week 16(Baseline to Week 16)
  • Change From Baseline in Diastolic Blood Pressure at Week 20(Baseline to Week 20)
  • Pulse at Week 1(Week 1)
  • Pulse at Week 6(Week 6)
  • Pulse at Week 26(Week 26)
  • Change From Baseline in Pulse at Week 4(Baseline to Week 4)
  • Change From Baseline in Pulse at Week 6(Baseline to Week 6)
  • Change From Baseline in Pulse at Week 16(Baseline to Week 16)
  • Change From Baseline in Pulse at Week 20(Baseline to Week 20)
  • Change From Baseline in Body Weight at Week 12(Baseline to Week 12)
  • Change From Baseline in Body Weight at Week 6 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit(Baseline to Week 6)
  • Percentage of Participants With New or Worsened Conditions in Mucobuccal Fold at Week 6 or When Withdrawn From Study(Week 6 or when withdrawn from study)
  • Change From Baseline in Body Weight at Week 12 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit(Baseline to Week 12)
  • Change From Baseline in Body Weight at Week 26 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit(Baseline to Week 26)
  • Percentage of Participants With New or Worsened Conditions in Lips/Labial Mucosa at Week 6 or When Withdrawn From Study(Week 6 or when withdrawn from study)
  • Percentage of Participants With New or Worsened Conditions in Gingiva at Week 6 or When Withdrawn From Study(Week 6 or when withdrawn from study)
  • Percentage of Participants With New or Worsened Conditions in Hard/Soft Palate at Week 6 or When Withdrawn From Study(Week 6 or when withdrawn from study)
  • Percentage of Participants With New or Worsened Conditions in Visual Mouth Inspection Overall at Week 6 or When Withdrawn From Study(Week 6 or when withdrawn from study)
  • Change From Baseline in Body Weight at Week 6(Baseline to Week 6)
  • Change From Baseline in Body Weight at Week 26(Baseline to Week 26)
  • Percentage of Participants With New or Worsened Conditions in Uvula/Oropharynx at Week 6 or When Withdrawn From Study(Week 6 or when withdrawn from study)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (6)

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