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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00356967
First received: July 26, 2006
Last updated: December 18, 2008
Last verified: December 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Smoking
 Drug: dianicline
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients
  • exhaled carbon monoxide testing
  • and plasma cotinine measurements

Secondary Outcome Measures:
  • questionnaire of smoking urge
  • Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal

Enrollment: 602
Study Start Date: June 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356967

Locations
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Denmark
Sanofi-Aventis Administrative Office
Horsholm, Denmark
France
Sanofi-Aventis Administrative Office
Paris, France
Norway
Sanofi-Aventis Administrative Office
Lysaker, Norway
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00356967     History of Changes
Other Study ID Numbers: EFC5515, EUDRACT : 2006-001009-20
Study First Received: July 26, 2006
Last Updated: December 18, 2008
Health Authority: Sweden: Medical Products Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by Sanofi:
smoking
cessation
tobacco
smoking cessation
tobacco use cessation

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 23, 2013