- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00358228
Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5 mg/Day or 20 mg/Day, Versus Placebo, as an Aid to Smoking Cessation (STRATUS US)
December 9, 2010 updated by: Sanofi
Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5 mg/Day or 20 mg/Day, Versus Placebo, as an Aid to Smoking Cessation (STRATUS US, EFC4964) - A Randomized, Double-blind, 3-arm, Placebo-controlled, Parallel-group, Fixed-dose, 52-week, Multi-center Study.
The primary study objective was to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers.
The secondary study objectives were:
- To evaluate the effects of rimonabant on craving and weight;
- To evaluate the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period
- To evaluate the population pharmacokinetics of rimonabant (ie, standard PK evaluation in the population of smokers);
- To observe the percentage of abstinent patients during a 40-week follow-up post treatment period;
- To evaluate quality of life (QOL) and pharmacoeconomics.
Study Overview
Study Type
Interventional
Enrollment (Actual)
787
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Malvern, Pennsylvania, United States, 19355
- Sanofi-Aventis Administrative Office
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Smokers smoking at least 10 cigarettes/day (on average) in the 2 months preceding screening visit;
- Motivated to quit smoking (Motivation Scale Score above or equal to 6 on a 10-point scale).
Exclusion Criteria:
- Smoked or consumed more than 3 times within the 3 months immediately preceding the screening visit: non tobacco cigarettes or related products or any form of tobacco product other than cigarettes;
- Current and regular consumption of marijuana (hashish).
- Met current criteria on the MINI International Neuropsychiatric Interview (MINI) for any of the following psychiatric disorders/states: major depressive episode, dysthymia, suicidality, manic episode or hypomanic episode, panic disorder, agoraphobia, social phobia (social anxiety disorder), obsessive compulsive disorder, posttraumatic stress disorder, alcohol dependence or abuse, substance dependence or abuse (excluding nicotine or caffeine), anorexia nervosa, bulimia nervosa, or generalized anxiety disorder;
- Met lifetime criteria on the MINI for manic episode or hypomanic episode, or psychotic disorders;
- Carried a diagnosis of, or suspicion of any cognitive disorder (eg, delirium, dementia, amnestic disorder) or any other psychiatric or developmental disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) that may interfere with his/her ability to understand or complete study related procedures;
- Had a history of severe depression, ie, those who have required hospitalization, or patients with 2 or more recurrent episodes of depression, or a history of multiple suicide attempts;
Had used, within 3 months before the screening visit:
- Nicotine replacement of any type for more than 3 days at the maximum prescribed dose, or
- Behavioral and/or motivational counseling, therapy, support group, or other procedure intended to assist smoking cessation on more than 3 days, or
- Bupropion (amphebutamone), or
- Systemic long acting corticosteroids, or
- Any therapy intended to treat or alleviate depressive symptoms (pharmacologic, somatic, or psychological) for more than 1 week.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Prolonged abstinence from tobacco smoking during the last 4 weeks of treatment (Day 43 to Day 70) as reported by direct inquiry of the patient by the Investigator, and confirmed by exhaled carbon monoxide (CO) levels, and plasma cotinine measurements.
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Secondary Outcome Measures
Outcome Measure |
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Analysis of mean change from baseline to last evaluation of the total score of QSU.
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Brief scale evaluating craving for tobacco cigarettes and relative change in body weight from baseline to last evaluation in patients with BMI lower than 30 kg/m2 at baseline achieving prolonged abstinence.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lowell C. DALE, MD, Mayo Clinic 200 First Street SW, Rochester, Minnesota 55905, US
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2002
Primary Completion (Actual)
August 1, 2003
Study Completion (Actual)
August 1, 2003
Study Registration Dates
First Submitted
July 28, 2006
First Submitted That Met QC Criteria
July 28, 2006
First Posted (Estimate)
July 31, 2006
Study Record Updates
Last Update Posted (Estimate)
December 10, 2010
Last Update Submitted That Met QC Criteria
December 9, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFC4964
- SR141716
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking Cessation
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University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
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Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
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Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
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Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of MiamiFlorida Department of HealthRecruitingSmoking Cessation | Tobacco Smoking | Tobacco Use CessationUnited States
-
The University of Hong KongNot yet recruitingSmoking Cessation Counseling Ability | Smoking Cessation Counseling PracticeHong Kong
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University of VermontMayo Clinic; Alaska Native Tribal Health ConsortiumTerminatedSmoking | Smoking CessationUnited States
-
University of Wisconsin, MadisonCentiment LLCCompletedSmoking | Smoking CessationUnited States
-
Yale UniversityCompletedSmoking | Smoking CessationUnited States
Clinical Trials on Rimonabant
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SanofiCompletedSmoking CessationFrance, Spain, Sweden, Switzerland, Belgium, Denmark, United Kingdom
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SanofiCompletedSmoking CessationUnited States
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SanofiTerminatedObesity | DyslipidemiasGermany, Netherlands, Turkey, Slovakia, United Kingdom, Finland, Hungary, Ireland, Italy, Norway, Greece, Sweden, Czech Republic, Portugal, Switzerland
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SanofiCompletedType 2 Diabetes MellitusUnited States, Poland, Germany, Netherlands, Argentina, Hungary, Chile
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SanofiCompletedMaintenance of Smoking CessationUnited States, Canada, Australia
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SanofiCompletedSmoking CessationUnited States
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SanofiTerminated
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SanofiCompletedCoronary AtherosclerosisCanada, United States, Italy, Spain, Poland, Netherlands, Belgium, France, Australia
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Weill Medical College of Cornell UniversityNational Institutes of Health (NIH); PWSAUSATerminatedPrader-willi SyndromeUnited States
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SanofiTerminatedObesity | Weight LossRomania, Netherlands, Croatia, Finland, Hungary