Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-02-27 @ 3:14 AM
Study NCT ID:
NCT00660751
Status:
COMPLETED
Last Update Posted:
2017-10-11
First Post:
2008-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Central Serotonergic and Adrenergic Systems in the Effectiveness of DNIC (Diffuse Noxious Inhibitory Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-10', 'studyFirstSubmitDate': '2008-04-15', 'studyFirstSubmitQcDate': '2008-04-16', 'lastUpdatePostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'level of DNIC', 'timeFrame': '1 week'}]}, 'conditionsModule': {'keywords': ['Physiology of Serotonergic and Adrenergic systems'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The role of central serotonergic and adrenergic systems in the effectiveness of DNIC (Diffuse Noxious Inhibitory Control) will be tested before and after taking Duloxetine and Placebo in a double blind study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n* age 18-80\n* no chronic disease\n\nExclusion Criteria:\n\n* Subjects who suffer from chronic pain / pain syndrome\n* use of anti-depressant or anti-psychotic drugs\n* food/ drugs sensitivity\n* breast feeding'}, 'identificationModule': {'nctId': 'NCT00660751', 'briefTitle': 'The Role of Central Serotonergic and Adrenergic Systems in the Effectiveness of DNIC (Diffuse Noxious Inhibitory Control', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'The Role of Central Serotonergic and Adrenergic Systems in the Effectiveness of DNIC (Diffuse Noxious Inhibitory Control', 'orgStudyIdInfo': {'id': 'DNIC01CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Duloxetine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Duloxetine']}], 'interventions': [{'name': 'Duloxetine', 'type': 'DRUG', 'description': 'SNRIs', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Prof. David Yarnitsky', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Neurology Department', 'investigatorFullName': 'd_yarnitsky', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}