Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-03-05 @ 3:30 AM
Study NCT ID:
NCT00115102
Status:
COMPLETED
Last Update Posted:
2006-06-20
First Post:
2005-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensory Examination and Pharmacological Modulation of Oral Hyperexcitability in Patients With Atypical Odontalgia and Matched Healthy Controls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014098', 'term': 'Toothache'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'C000629870', 'term': 'Esketamine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-06', 'completionDateStruct': {'date': '2005-10'}, 'lastUpdateSubmitDate': '2006-06-15', 'studyFirstSubmitDate': '2005-06-20', 'studyFirstSubmitQcDate': '2005-06-20', 'lastUpdatePostDateStruct': {'date': '2006-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-06-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain'}, {'measure': 'Sensitivity to heat and cold'}, {'measure': 'Sensitivity to mechanical stimuli'}]}, 'conditionsModule': {'keywords': ['Atypical odontalgia', 'capsaicin', 'pain', 'neuropathic pain'], 'conditions': ['Odontalgia']}, 'descriptionModule': {'briefSummary': 'This project examines experimental pain and chronic pain in the mouth, specifically the condition called atypical odontalgia (AO:atypical toothpain). In 16 patients with AO and 16 healthy persons, capsaicin (chili-pepper) is applied to the gingiva to cause pain. This pain is evaluated by the participants. In three sessions, 3 different medications are tested for effect on the pain. The medications are fentanyl, S-ketamine and placebo-treatment (saline). The aim is to know more about pain mechanisms in AO in order to develop an effective treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Atypical odontalgia\n\nExclusion Criteria:\n\n* BMI \\> 30\n* Heart conditions\n* Lung disease\n* Diseases of the liver or kidneys\n* Hypertension, untreated'}, 'identificationModule': {'nctId': 'NCT00115102', 'briefTitle': 'Sensory Examination and Pharmacological Modulation of Oral Hyperexcitability in Patients With Atypical Odontalgia and Matched Healthy Controls', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'orgStudyIdInfo': {'id': 'AO1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'fentanyl', 'type': 'DRUG'}, {'name': 'S-ketamine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Danish Pain Research Center', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Troels Staehelin Jensen, MD, PhD, Dr.Sci', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Pain Research Center', 'class': 'OTHER'}]}}}