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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: Federal Agency for Medicines and Health Products, FAMHP

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

ClinicalTrials.gov processed this record on September 22, 2014