EUCTR2006-005334-21-DE
Active, not recruiting
Not Applicable
A randomized, double-blind, placebo-controlled, parallel group, fixed-dose, 8-weektreatment, multi-center trial evaluating the dose effect relationship for efficacy and the safety of 3 oral doses of surinabant: 2.5, 5 and 10mg/day as an aid to smoking cessation in cigarette smokers - SURSMOKE
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aid to smoking cessation in cigarette smokers
- Sponsor
- sanofi-aventis recherche et developpement
- Enrollment
- 805
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients over legal age, smoking at least 10 cigarettes/day as a mean within the 6 months preceding the screening visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Related to study methodology
- •1\. Level of motivation to quit less than 6 on a ten\-point Likert Scale.
- •2\. Refusal or inability to give informed consent to participate in the study.
- •3\. Not able to follow verbal and written instructions and to complete all aspects of the study.
- •4\. Other participant in a household enrolled in the study.
- •5\. Patients who have a history of multiple allergic reactions to medications in two drug classes.
- •6\. Patients who have taken an investigational drug within the past 6 months prior to the screening visit.
- •7\. 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 days within the 3 months preceding the screening visit.
- •8\. Patients dependent to alcohol or illicit drugs.
- •9\. Patients who have smoked or consumed marijuana in any form on more than one
Outcomes
Primary Outcomes
Not specified
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