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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Smoking

Treatments: Drug: dianicline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00356967

EFC5515

EUDRACT : 2006-001009-20

Details and patient eligibility

About

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.

Enrollment: 602 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind