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Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking Cessation (EURODIAN)
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00356967
First received: July 26, 2006
Last updated: December 18, 2008
Last verified: December 2008
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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 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 |
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 (Adult, Senior) |
| 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
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
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:
| 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 |
Keywords provided by Sanofi:
|
smoking cessation tobacco smoking cessation tobacco use cessation |
ClinicalTrials.gov processed this record on September 19, 2017