Efficacy and Safety of Dianicline Treatment as an Aid to Smoking Cessation in Cigarette Smokers (AMERIDIAN)

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00387946
• Other study ID #: EFC5514
• Secondary ID: SSR591813
• Status: Completed
• Phase: Phase 3
• First received: October 12, 2006
• Last updated: February 15, 2012
• Start date: September 2006
• Est. completion date: September 2007

Study information

• Verified date: February 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Outpatients, over legal age, smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit.

Exclusion Criteria:

• Patients who have taken an investigational drug within the past six months prior to the screening visit.

• Patients who had a previous quit attempt (= or >1 day with the aid of pharmacological adjunct) in the previous three months (before screening).

• Patients who have smoked or consumed non-tobacco cigarettes or any form of tobacco product (other than cigarettes such as cigars, pipes, smokeless tobacco, etc) more than 3 times within the 3 months preceding the screening visit.

• Patients who currently present with (based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV]):

• Psychotic disorder

• Major depressive episode

• Pregnant or breast-feeding women.

• Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy. Medically acceptable methods of birth control for this study include approved hormonal contraceptive medications or devices, approved intra-uterine contraceptive devices, use of two combined barrier methods.

• Patients who have suffered from a myocardial infarction, unstable angina or other major cardiovascular event within the past week prior to screening.

• Patients who have a history of multiple allergic reactions to medications in two drug classes.

• Patients who have QTcF > 500 ms on the electrocardiogram (ECG).

• Patients with mild, moderate or severe renal impairment.

• Patients who have an abnormal laboratory test of potential clinical significance at screening.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Use Cessation

Intervention

Drug:
• SSR591813L (dianicline)

Locations

Country	Name	City	State
Canada	Administrative Office	Laval	Quebec
United States	Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Questionnaire of Smoking Urges to assess craving for cigarettes; Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal, number of smoke-free days, and average number of cigarettes smoked from smoking status interview