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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00356967
First Posted: July 27, 2006
Last Update Posted: December 19, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
July 26, 2006
July 27, 2006
December 19, 2008
June 2006
June 2007   (Final data collection date for primary outcome measure)
  • 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
  • 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
Complete list of historical versions of study NCT00356967 on ClinicalTrials.gov Archive Site
  • questionnaire of smoking urge
  • Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal
  • Questionnaire of smoking urge, Hughes and Hatsukami Minesota Withdrawal Scale
  • to measure nicotine withdrawal
Not Provided
Not Provided
 
Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking Cessation
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Smoking
Drug: dianicline
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
602
June 2007
June 2007   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Denmark,   France,   Norway,   Spain,   Sweden
Netherlands
 
NCT00356967
EFC5515
EUDRACT : 2006-001009-20
Not Provided
Not Provided
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP