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

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ClinicalTrials.gov Identifier: NCT00387946
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : February 17, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Tobacco Use Cessation Drug: SSR591813L (dianicline) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : September 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00387946


Locations
United States, New Jersey
Administrative Office
Bridgewater, New Jersey, United States, 08807
Canada, Quebec
Administrative Office
Laval, Quebec, Canada
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00387946     History of Changes
Other Study ID Numbers: EFC5514
SSR591813
First Posted: October 13, 2006    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012

Keywords provided by Sanofi:
smoking
cessation
tobacco