Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT01712451
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2012-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose-ranging Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068297', 'term': 'Fluticasone-Salmeterol Drug Combination'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}], 'ancestors': [{'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'dispFirstSubmitDate': '2015-03-05', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-05', 'studyFirstSubmitDate': '2012-10-16', 'dispFirstSubmitQcDate': '2015-03-05', 'studyFirstSubmitQcDate': '2012-10-19', 'dispFirstPostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '8 weeks treatment', 'description': 'physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events'}, {'measure': 'Change in abdominal circumference', 'timeFrame': 'Baseline to 9 weeks', 'description': 'abdominal circumference'}], 'secondaryOutcomes': [{'measure': 'Change in global clinician scale score', 'timeFrame': 'Baseline to 9 weeks'}, {'measure': 'Change in global patient scale score', 'timeFrame': 'Baseline to 9 weeks'}, {'measure': 'Change in Photonumeric scale score', 'timeFrame': 'Baseline to 9 weeks'}, {'measure': 'Change in Patient Reported Outcome Score', 'timeFrame': 'Baseline to 9 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adiposity'], 'conditions': ['Abdominal Contour Defects']}, 'descriptionModule': {'briefSummary': 'Dose ranging study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 45 years of age inclusive\n* abdominal contour defect\n* BMI \\<25 kg/msq\n* Stable diet and exercise and body weight\n\nExclusion Criteria:\n\n* Prior treatment of abdominal contour defects (liposuction, abdominoplasty, etc)\n* Known hypersensitivity to study drugs'}, 'identificationModule': {'nctId': 'NCT01712451', 'acronym': 'LIPO-102-CL-11', 'briefTitle': 'Dose-ranging Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neothetics, Inc'}, 'officialTitle': 'Dose-ranging Study of the Safety and Efficacy of Fluticasone Propionate and Salmeterol Xinafoate in Healthy Patients With Abdominal Contour Defects', 'orgStudyIdInfo': {'id': 'LIPO-102-CL-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LIPO-102, Low', 'interventionNames': ['Drug: salmeterol xinafoate, fluticasone propionate']}, {'type': 'EXPERIMENTAL', 'label': 'LIPO-102, Mid', 'interventionNames': ['Drug: salmeterol xinafoate, fluticasone propionate']}, {'type': 'EXPERIMENTAL', 'label': 'LIPO-102, High', 'interventionNames': ['Drug: salmeterol xinafoate, fluticasone propionate']}, {'type': 'EXPERIMENTAL', 'label': 'LIPO-102; Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'salmeterol xinafoate', 'interventionNames': ['Drug: salmeterol xinafoate']}], 'interventions': [{'name': 'salmeterol xinafoate, fluticasone propionate', 'type': 'DRUG', 'otherNames': ['LIPO-102'], 'description': 'LIPO-102', 'armGroupLabels': ['LIPO-102, High', 'LIPO-102, Low', 'LIPO-102, Mid']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['LIPO-102; Placebo']}, {'name': 'salmeterol xinafoate', 'type': 'DRUG', 'description': 'Salmeterol', 'armGroupLabels': ['salmeterol xinafoate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}], 'overallOfficials': [{'name': 'Murray Maytom', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Neothetics, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neothetics, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}