Who is sponsoring NCT00387946?

NCT00387946 is sponsored by Sanofi.

What condition does NCT00387946 study?

NCT00387946 studies Smoking Cessation, Tobacco Use Cessation.

What drugs are being tested in NCT00387946?

Interventions: SSR591813L (dianicline).

What is the status of NCT00387946?

NCT00387946 is currently COMPLETED.

Last reviewed 2012-02-15 · How we verify

An International, Seven-week, Double-blind, Placebo-controlled, Two Parallel Group Study to Assess the Efficacy of Dianicline 40 mg Bid as an Aid to Smoking Cessation in Cigarette Smokers

NCT00387946 Phase 3 COMPLETED

The primary study 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 safety of dianicline.

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	630
Start date	2006-09
Completion	2007-09

Conditions

Smoking Cessation
Tobacco Use Cessation

Interventions

SSR591813L (dianicline)

Primary outcomes

To assess the continuous abstinence from tobacco smoking at every visit during the last 4 weeks of treatment period, i.e. from week 4 to week 7, through direct inquiry of patients, exhaled carbon monoxide (CO) testing, and plasma cotinine measurements

Countries

United States, Canada