Viewing Study NCT01937702


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Study NCT ID: NCT01937702
Status: COMPLETED
Last Update Posted: 2014-12-30
First Post: 2013-08-27
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: A Trial Investigating the Influence of Injection Speed and Volume on the Perception of Subcutaneous Injection Pain
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-29', 'studyFirstSubmitDate': '2013-08-27', 'studyFirstSubmitQcDate': '2013-09-04', 'lastUpdatePostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'injection pain', 'timeFrame': 'within 24 hours after injection'}], 'secondaryOutcomes': [{'measure': 'variability of injection pain', 'timeFrame': 'within the first 24 hours after injection'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'A trial, investigating the influence of injection speed and volume on the perception of subcutaneous injection pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has signed the informed consent form prior to screening\n* Age 18-74 years at screening (both included)\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit\n* Previous participation in this trial. Participation is defined as having received at least one injection'}, 'identificationModule': {'nctId': 'NCT01937702', 'briefTitle': 'A Trial Investigating the Influence of Injection Speed and Volume on the Perception of Subcutaneous Injection Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Profil Institut für Stoffwechselforschung GmbH'}, 'officialTitle': 'A Trial Investigating the Influence of Injection Speed and Volume on the Perception of Subcutaneous Injection Pain', 'orgStudyIdInfo': {'id': 'PSIP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anti-diabetes medication', 'description': 'Insulin', 'interventionNames': ['Other: 0.9% NaCl (sodium chloride)']}], 'interventions': [{'name': '0.9% NaCl (sodium chloride)', 'type': 'OTHER', 'armGroupLabels': ['Anti-diabetes medication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55116', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Profil Mainz GmbH & Co. KG', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'overallOfficials': [{'name': 'Thomas Forst, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Profil Mainz GmbH & Co KG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Profil Institut für Stoffwechselforschung GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}