Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-26 @ 5:58 AM
Study NCT ID:
NCT05340192
Status:
COMPLETED
Last Update Posted:
2022-04-22
First Post:
2022-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Octreotide on Saliva
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015282', 'term': 'Octreotide'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a healthy volunteer pilot study. Subjects will be asked to provide a saliva sample after a 2 hour fast and 5 minutes after rinsing their mouth with tap water. The sample will be collected in an Eppendorf vial. After providing the saliva sample, each subject will be injected subcutaneously with 100 mcg (1 ml) of Octreotide by either a physician or registered nurse. A second sample of saliva will be collected using the same protocol 45-55 minutes after administering the drug.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-15', 'studyFirstSubmitDate': '2022-04-15', 'studyFirstSubmitQcDate': '2022-04-15', 'lastUpdatePostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To quantify the change of saliva proteomes of subjects pre-octreotide treatment', 'timeFrame': 'Day 1 pre-treatment', 'description': 'Saliva samples analyzed using quantitative LC/MS/MS using a nanAcquity UPLC system (Waters Corp) coupled to a Thermo Orbitrap Fusion Lumos high resolution accurate mass tandem mass spectrometer (Thermo) via a nanoelectrospray ionization source'}, {'measure': 'To quantify the change of saliva proteomes of subjects post-octreotide treatment', 'timeFrame': 'Day 1 post-treatment', 'description': 'Saliva samples analyzed using quantitative LC/MS/MS using a nanAcquity UPLC system (Waters Corp) coupled to a Thermo Orbitrap Fusion Lumos high resolution accurate mass tandem mass spectrometer (Thermo) via a nanoelectrospray ionization source'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of Octreotide on saliva enzymes. The study team hypothesizes that Octreotide will decrease the levels of certain proteins, specifically the metalloproteinase family.', 'detailedDescription': 'This is a healthy volunteer pilot study. The purpose of this study is to determine the effect of a drug, Octreotide, on saliva enzymes in order to see if this drug can help prevent pharyngo-cutaneous fistulas (an abnormal tissue connection in the pharynx) in patients undergoing laryngectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adults between the ages of 18-40 years old\n* Healthy volunteer who is willing to undergo research activities\n* Healthy volunteer with no self-report of disease, oral symptoms or lesions, or cold or flu like symptoms that would affect the reflective measurements in the oral cavity\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Pregnant or nursing women\n* Children under the age of 18 or adults over 40\n* Complaint of oral symptoms (self-reported)\n* Medical condition affecting saliva (e.g. Sjogren's)\n* History of head/neck radiation\n* Medication that might affect saliva (e.g. Proton Pump Inhibitors)\n* Known allergy to Octreotide\n* Non-English speaking\n* Diabetes, gallbladder disease, heart disease, high blood pressure, a heart rhythm disorder, thyroid problems, pancreatitis, kidney disease, or liver disease (self-reported)"}, 'identificationModule': {'nctId': 'NCT05340192', 'briefTitle': 'Effect of Octreotide on Saliva', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Effect of Octreotide on Saliva', 'orgStudyIdInfo': {'id': 'Pro00100579'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy Volunteer', 'description': 'Octreotide, 100 mcg (1 ml) s.c.', 'interventionNames': ['Drug: Octreotide 1 MG/ML']}], 'interventions': [{'name': 'Octreotide 1 MG/ML', 'type': 'DRUG', 'description': '100 mcg (1 ml) of Octreotide', 'armGroupLabels': ['Healthy Volunteer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Walter Lee, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}