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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking | Drug: dianicline | Phase 3 |
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 |

- 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
- questionnaire of smoking urge
- Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
Study Director: | ICD CSD | Sanofi |
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 |
First Posted: | July 27, 2006 Key Record Dates |
Last Update Posted: | December 19, 2008 |
Last Verified: | December 2008 |
smoking cessation tobacco smoking cessation tobacco use cessation |