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

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.
 
ClinicalTrials.gov Identifier: NCT00356967
Recruitment Status : Completed
First Posted : July 27, 2006
Last Update Posted : December 19, 2008
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Drug: dianicline Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 602 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356967


Locations
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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
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Study Director: ICD CSD Sanofi
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00356967     History of Changes
Other Study ID Numbers: EFC5515
EUDRACT : 2006-001009-20
First Posted: July 27, 2006    Key Record Dates
Last Update Posted: December 19, 2008
Last Verified: December 2008
Keywords provided by Sanofi:
smoking
cessation
tobacco
smoking cessation
tobacco use cessation