Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-03-01 @ 5:38 PM
Study NCT ID:
NCT00356967
Status:
COMPLETED
Last Update Posted:
2008-12-19
First Post:
2006-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D020340', 'term': 'Tobacco Use Cessation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C475773', 'term': 'dianicline'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 602}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-18', 'studyFirstSubmitDate': '2006-07-26', 'studyFirstSubmitQcDate': '2006-07-26', 'lastUpdatePostDateStruct': {'date': '2008-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients'}, {'measure': 'exhaled carbon monoxide testing'}, {'measure': 'and plasma cotinine measurements'}], 'secondaryOutcomes': [{'measure': 'questionnaire of smoking urge'}, {'measure': 'Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal'}]}, 'conditionsModule': {'keywords': ['smoking', 'cessation', 'tobacco', 'smoking cessation', 'tobacco use cessation'], 'conditions': ['Smoking']}, 'referencesModule': {'references': [{'pmid': '37142273', 'type': 'DERIVED', 'citation': 'Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.'}], 'seeAlsoLinks': [{'url': 'http://www.sanofi-aventis.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary 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 the safety of dianicline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients over the legal age smoking at least 10 cigarettes per day for at least 2 months\n\nExclusion Criteria:\n\n* Insufficient level of motivation\n* Another participant in the household\n* Patients with current psychotic disorder or major depressive disorder\n\nThe investigator will evaluate whether there are other reasons why a patient may not participate.'}, 'identificationModule': {'nctId': 'NCT00356967', 'acronym': 'EURODIAN', 'briefTitle': 'Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking Cessation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An International 7-Week, Double-Blind, Placebo-Controlled, 2-Parallel Group Study to Assess the Efficacy of Dianicline 40 mg BID as an Aid to Smoking Cessation in Cigarette Smokers', 'orgStudyIdInfo': {'id': 'EFC5515'}, 'secondaryIdInfos': [{'id': 'EUDRACT : 2006-001009-20'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'dianicline', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Diegem', 'country': 'Belgium', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 50.89727, 'lon': 4.43354}}, {'city': 'Hørsholm', 'country': 'Denmark', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 55.88098, 'lon': 12.50111}}, {'city': 'Paris', 'country': 'France', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Lysaker', 'country': 'Norway', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 59.90994, 'lon': 10.63545}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Bromma', 'country': 'Sweden', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 59.34, 'lon': 17.94}}], 'overallOfficials': [{'name': 'ICD CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'ICD Study Director', 'oldOrganization': 'sanofi-aventis'}}}}