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

Smoking Clinical Trial

— EURODIAN  

Official title:

An International 7-Week, Double-Blind, Placebo-Controlled, 2-Parallel Group Study to Assess the Efficacy of Dianicline 40 mg BID as an Aid to Smoking Cessation in Cigarette Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356967
• Other study ID #: EFC5515
• Secondary ID: EUDRACT : 2006-0
• Status: Completed
• Phase: Phase 3
• First received: July 26, 2006
• Last updated: December 18, 2008
• Start date: June 2006
• Est. completion date: June 2007

Study information

• Verified date: December 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

Drug:
• dianicline

Locations

Country	Name	City	State
Belgium	Sanofi-Aventis Administrative Office	Diegem
Denmark	Sanofi-Aventis Administrative Office	Horsholm
France	Sanofi-Aventis Administrative Office	Paris
Norway	Sanofi-Aventis Administrative Office	Lysaker
Spain	Sanofi-Aventis Administrative Office	Barcelona
Sweden	Sanofi-Aventis Administrative Office	Bromma

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Belgium,  Denmark,  France,  Norway,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients
Primary	exhaled carbon monoxide testing
Primary	and plasma cotinine measurements
Secondary	questionnaire of smoking urge
Secondary	Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal

External Links

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