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临床试验/NCT01323491
NCT01323491已完成不适用

Nicht-interventionelle Studie (NIS) Zur Strukturierten Raucherentwöhnung Nach Dem Konzept "EINFACH ERFOLGREICH RAUCHFREI" unterstützt Durch NICROETTE®-Produkte

Johnson & Johnson GmbH1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
184
试验地点
1
主要终点
Further knowledge of smoking cessation in would-be non-smokers

研究概览

简要总结

The actually most accepted method of effective smoking cessation is based on structured consultation and medical care in combination with supportive medical treatment. A group of experts developed the concept "EINFACH ERFOLGREICH RAUCHFREI" ("EASY EFFECTIVE SMOKELESS") for general practitioners providing a structured compendium for negotiation.

Physicians who have implemented this concept will conduct this non-interventional study. The implementation of the scheme will be investigated under general practice conditions and the applicability of the concept has to be assessed by the physicians.

In addition further knowledge of smoking cessation in would-be non-smokers which decided to quit, supported by medical treatment with NICORETTE®-products, will be documented for a large patient collective under real practice conditions.

To answer all above mentioned questions for a sufficient number of patients a multicenter, prospective non-interventional study design was used for this trial as only this instrument detects characteristics of the physicians' treatment without any further input or other influences.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Routine smokers
  • Nicotine replacement therapy with Nicorette® according to physicians treatment decision

排除标准

  • Pregnancy
  • Contraindication according to Summary of Product Characteristics (SPC)
  • Other nicotine replacement therapy during the last month

研究组 & 干预措施

routine smokers

would-be non-smokers, no actual nicotine replacement therapy

干预措施: Nicotine replacement therapy (Drug)

结局指标

主要结局

Further knowledge of smoking cessation in would-be non-smokers

时间窗: Baseline (about 2 weeks before date of smoking cessation), Follow-up (about 3, 14 and 28 days after date of smoking cessation), Final examination (about 3 months after date of smoking cessation)

次要结局

未报告次要终点

研究者

发起方
Johnson & Johnson GmbH
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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