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CompletedNCT00356967EURODIANUpdated Dec 19, 2008

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

A Phase 3 interventional study of dianicline in Smoking, sponsored by Sanofi. Completed at 6 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-12-19.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
602
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Smoking

Keywords

  • smoking
  • cessation
  • tobacco
  • smoking cessation
  • tobacco use cessation
03

In context

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
602 participants (actual)

Interventions

  • Drugdianicline
06

What researchers measure

Primary outcomes

  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 outcomes

  1. questionnaire of smoking urge

  2. Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal

07

Study locations

6 sites
  • Sanofi-Aventis Administrative Office
    Diegem, Belgium
  • Sanofi-Aventis Administrative Office
    Horsholm, Denmark
  • Sanofi-Aventis Administrative Office
    Paris, France
  • Sanofi-Aventis Administrative Office
    Lysaker, Norway
  • Sanofi-Aventis Administrative Office
    Barcelona, Spain
  • Sanofi-Aventis Administrative Office
    Bromma, Sweden
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00356967
Lead sponsor
Sanofi
First posted
Jul 27, 2006
Start date
Jun 2006
Primary completion
Jun 2007
Completion
Jun 2007
Last update
Dec 19, 2008

Study contacts

ICD CSD
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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