Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking Cessation

NCT ID: NCT00356967

Last Updated: 2008-12-19

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

Clinical Phase

PHASE3

Total Enrollment

602 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-06-30

Brief Summary

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The primary objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are: to assess the craving for cigarettes, nicotine withdrawal symptoms and the safety of dianicline.

Detailed Description

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Conditions

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Smoking

Keywords

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smoking cessation tobacco smoking cessation tobacco use cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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dianicline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Outpatients over the legal age smoking at least 10 cigarettes per day for at least 2 months

Exclusion Criteria

* Insufficient level of motivation
* Another participant in the household
* Patients with current psychotic disorder or major depressive disorder

The investigator will evaluate whether there are other reasons why a patient may not participate.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

Diegem, , Belgium

Site Status

Sanofi-Aventis Administrative Office

Hørsholm, , Denmark

Site Status

Sanofi-Aventis Administrative Office

Paris, , France

Site Status

Sanofi-Aventis Administrative Office

Lysaker, , Norway

Site Status

Sanofi-Aventis Administrative Office

Barcelona, , Spain

Site Status

Sanofi-Aventis Administrative Office

Bromma, , Sweden

Site Status

Countries

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Netherlands Belgium Denmark France Norway Spain Sweden

References

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Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

Reference Type DERIVED
PMID: 37142273 (View on PubMed)

Related Links

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Other Identifiers

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EUDRACT : 2006-001009-20

Identifier Type: -

Identifier Source: secondary_id

EFC5515

Identifier Type: -

Identifier Source: org_study_id