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
Verified date | February 2012 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Administrative Office | Laval | Quebec |
United States | Administrative Office | Bridgewater | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
United States, Canada,
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 |
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