Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
Study NCT ID:
NCT00464256
Status:
COMPLETED
Last Update Posted:
2010-12-10
First Post:
2007-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Efficacy and Safety of Rimonabant 20mg/Day Versus Placebo in Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077285', 'term': 'Rimonabant'}], 'ancestors': [{'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 533}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-09', 'studyFirstSubmitDate': '2007-04-20', 'studyFirstSubmitQcDate': '2007-04-20', 'lastUpdatePostDateStruct': {'date': '2010-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) and cotinine measurements'}], 'secondaryOutcomes': [{'measure': 'Efficacy: mean change of the total score of Questionnaire on Smoking Urges (QSU) brief scale, categorical change in body weight in subjects with Body Mass Index lower than 30 kg/m² at baseline who achieve prolonged abstinence'}, {'measure': 'Safety data'}]}, 'conditionsModule': {'keywords': ['abstinence'], 'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'The primary objective is to assess the efficacy a 20mg/day fixed dose of rimonabant versus placebo on abstinence from tobacco use in cigarette smoker.\n\nThe secondary objective is to evaluate the effects of rimonabant on craving and weight and on the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Smokers smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit\n* Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale\n\nExclusion Criteria:\n\n* Non tobacco cigarettes consumption\n* Chronic use of marijuana\n* Pregnancy, breastfeeding\n* Any clinically significant disease that might interfere with the efficacy or safety evaluation of the study drug\n* Concomitant use of drugs as an aid to smoking cessation or that might induce weight change'}, 'identificationModule': {'nctId': 'NCT00464256', 'acronym': 'STRATUS-META', 'briefTitle': 'Comparison of Efficacy and Safety of Rimonabant 20mg/Day Versus Placebo in Smoking Cessation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Comparison of the Efficacy and Safety of a 20 mg/Day Oral Dose of Rimonabant Versus Placebo as an Aid to Smoking Cessation - a US, Randomized, Double-blind, 2 Arm, Placebo-controlled, Parallel-group, Fixed Dose, 12-week Study', 'orgStudyIdInfo': {'id': 'EFC5794'}, 'secondaryIdInfos': [{'id': 'SR141716'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'rimonabant', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Trial Transparency Team', 'oldOrganization': 'sanofi-aventis'}}}}