"EASY EFFECTIVE SMOKELESS" With NICORETTE®

NCT ID: NCT01323491

Last Updated: 2013-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

184 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stereotyped Behavior Tobacco Smoking Behavior

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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routine smokers

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

Nicotine replacement therapy

Intervention Type DRUG

Nicorette® TX tape 10mg, 15mg, 25mg Nicorette® microtab 2mg Nicorette® inhaler 10mg Nicorette® chewing gum 2 mg, 4mg freshfruit, freshmint, mint, whitemint

Interventions

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Nicotine replacement therapy

Nicorette® TX tape 10mg, 15mg, 25mg Nicorette® microtab 2mg Nicorette® inhaler 10mg Nicorette® chewing gum 2 mg, 4mg freshfruit, freshmint, mint, whitemint

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy
* Contraindication according to Summary of Product Characteristics (SPC)
* Other nicotine replacement therapy during the last month
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anfomed GmbH

INDUSTRY

Sponsor Role collaborator

Johnson & Johnson GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Johnson & Johnson GmbH

Neuss, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EER Nicorette - 01

Identifier Type: -

Identifier Source: org_study_id

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