Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-29 @ 11:34 AM
Study NCT ID:
NCT00377806
Status:
COMPLETED
Last Update Posted:
2007-12-10
First Post:
2006-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-07', 'studyFirstSubmitDate': '2006-09-15', 'studyFirstSubmitQcDate': '2006-09-15', 'lastUpdatePostDateStruct': {'date': '2007-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The area under the curve (AUC) of the symptom score (pain, temperature and size of erythema along the superficial vein)'}], 'secondaryOutcomes': [{'measure': "Patient's global assessment of drug effect at each visit"}, {'measure': "Physician's global assessment of drug effect at each visit"}, {'measure': 'AUC of assessment of pain (visual analog scale) between treatment day 1 and day 5'}, {'measure': 'AUC of assessment of inflammatory area of the superficial thrombophlebitis between treatment day 1 and 5'}, {'measure': 'AUC of assessment of temperature of inflammatory area around superficial thrombophlebitis between treatment day 1 and 5'}]}, 'conditionsModule': {'keywords': ['Superficial thrombophlebitis, diclofenac gel, non steroidal antiinflammatory drugs'], 'conditions': ['Superficial Thrombophlebitis of the Upper Limb']}, 'descriptionModule': {'briefSummary': 'This study will assess the efficacy, safety and tolerability of topically administered diclofenac gel versus placebo with respect to the symptom score (pain, temperature and size of erythema along the superficial vein)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with indication of topical treatment for inflammatory, painful superficial thrombophlebitis of the upper limb\n* Spontaneous or iatrogenic superficial thrombophebitis of the upper limb\n\nExclusion Criteria:\n\n* Hypersensitivity to the study drug, to actylsalicyclic acid and other non-steroidal antirheumatic agents and to the ingredients of the gel\n* Paitents who had developed asthma, skin reactions or acute rhinitis to acetylsalicylic acid or other non-steroidal antirheumatic agents in the past\n* Therapy with varicose vein remedies, antithrombotic or antiphlogistic agents as well as corticosteroids for more than 7 days prior to study start\n* Acute deep vein thrombosis and thrombophlebitis extending into other deep veins\n\nOther protocol-defined exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00377806', 'briefTitle': 'Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A One Week, Double-Blind, Adaptive, Randomized, Multicenter Study to Compare the Efficacy, Safety and Tolerability of Topical Diclofenac Gel Versus Placebo in Patients With Superficial Thrombophlebitis', 'orgStudyIdInfo': {'id': 'CVOL458UDE01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Diclofenac gel', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Novartis', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}}}}