Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT01227720
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2010-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095488', 'term': 'Nicotine Replacement Therapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-06', 'studyFirstSubmitDate': '2010-10-22', 'studyFirstSubmitQcDate': '2010-10-22', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration', 'timeFrame': 'during 12 hours after product administration', 'description': 'The maximum observed nicotine concentration in plasma (Cmax)'}, {'measure': 'Area under the Curve', 'timeFrame': 'after 12 hours', 'description': 'The area under the plasma concentration-vs-time curve until the last measurable concentration (AUCt) and the area under the plasma concentration-vs.-time curve until infinity (AUC∞)'}], 'secondaryOutcomes': [{'measure': 'Time of Maximum Concentration', 'timeFrame': 'during 12 hours after start of product administration', 'description': 'The time of occurrence of maximum concentration (Tmax)'}, {'measure': 'Terminal Elimination Rate Constant', 'timeFrame': 'during 12 hours after start of product administration', 'description': 'The terminal nicotine elimination rate constant (λz)'}, {'measure': 'Oral Dissolution Time', 'timeFrame': 'from administration until completely dissolved', 'description': 'Actual time required for oral dissolution'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking Cessation, Nicotine pharmacokinetics'], 'conditions': ['Tobacco Dependence']}, 'descriptionModule': {'briefSummary': 'Comparative pharmacokinetic study of new oral nicotine replacement therapy products.', 'detailedDescription': 'This study compares new oral Nicotine Replacement Therapy (NRT) products containing 2 and 4 mg nicotine with NiQuitin™ lozenge 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of treatment A, B, C, and D are given once in the morning during separate treatment visits scheduled in a crossover setting with randomized treatment sequences, also including a fifth treatment visit with either treatment E or F. The study will include 104 healthy smokers between the ages of 19 and 50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. The study will be performed at two sites with 52 subjects at each site. Subjects and study personnel will be aware of which treatment is administered at a given visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.\n* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.\n* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.\n\nExclusion Criteria:\n\n* Pregnancy, lactation or intended pregnancy.\n* Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.'}, 'identificationModule': {'nctId': 'NCT01227720', 'briefTitle': 'Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Consumer and Personal Products Worldwide'}, 'officialTitle': 'Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products - A Study in Healthy Smokers.', 'orgStudyIdInfo': {'id': 'NICTDP1076'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A NSL2L', 'description': 'Experimental Nicotine Replacement Therapy (NRT)(L) 2 mg', 'interventionNames': ['Drug: Experimental Nicotine Replacement Therapy (NRT) 2 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B Lozenge', 'description': 'Marketed Nicotine Lozenge 2 mg', 'interventionNames': ['Drug: Marketed Nicotine Lozenge']}, {'type': 'EXPERIMENTAL', 'label': 'C NSL4M', 'description': 'Experimental NRT (M) 4 mg', 'interventionNames': ['Drug: Experimental Nicotine Replacement Therapy (NRT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'D Lozenge', 'description': 'Marketed Nicotine Lozenge 4 mg', 'interventionNames': ['Drug: Marketed Nicotine Lozenge']}, {'type': 'EXPERIMENTAL', 'label': 'E NSL4L', 'description': 'Experimental NRT (L) 4 mg', 'interventionNames': ['Drug: Experimental Nicotine Replacement Therapy (NRT)']}, {'type': 'EXPERIMENTAL', 'label': 'F NSL4H', 'description': 'Experimental NRT (H) 4 mg', 'interventionNames': ['Drug: Experimental Nicotine Replacement Therapy (NRT)']}], 'interventions': [{'name': 'Experimental Nicotine Replacement Therapy (NRT) 2 mg', 'type': 'DRUG', 'otherNames': ['Not yet marketed'], 'description': '2 mg Single-dose of new NRT product (NSL2L)', 'armGroupLabels': ['A NSL2L']}, {'name': 'Experimental Nicotine Replacement Therapy (NRT)', 'type': 'DRUG', 'otherNames': ['Not yet marketed'], 'description': '4 mg Single-dose of new NRT product', 'armGroupLabels': ['C NSL4M', 'E NSL4L', 'F NSL4H']}, {'name': 'Marketed Nicotine Lozenge', 'type': 'DRUG', 'otherNames': ['NiQuitin™ lozenge'], 'description': '2 mg Single-dose of marketed lozenge', 'armGroupLabels': ['B Lozenge']}, {'name': 'Marketed Nicotine Lozenge', 'type': 'DRUG', 'otherNames': ['NiQuitin™ lozenge'], 'description': '4 mg Single-dose of marketed lozenge', 'armGroupLabels': ['D Lozenge']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-221 85', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Lund University Hospital Clinical Trial Unit', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': 'SE-222 20', 'city': 'Lund', 'country': 'Sweden', 'facility': 'McNeil AB Clinical Pharmacology R&D', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Elisabeth Kruse, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'McNeil AB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McNeil AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}