Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-01 @ 8:47 AM
Study NCT ID:
NCT00628004
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2008-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007871', 'term': 'Leg Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2008-02-20', 'studyFirstSubmitQcDate': '2008-03-03', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Week 1, 6, 20, 33, 46'}], 'secondaryOutcomes': [{'measure': 'Clinical occurrences', 'timeFrame': 'Week 1, 6, 20, 33, 46'}, {'measure': 'Ulcer area reduction', 'timeFrame': 'Week 1, 6, 20, 33, 46'}, {'measure': 'Ulcer status', 'timeFrame': 'Week 1, 6, 20, 33, 46'}, {'measure': 'Skin condition at healed ulcer location', 'timeFrame': 'Week 1, 6, 20, 33, 46'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Leg Ulcers']}, 'descriptionModule': {'briefSummary': 'The objective of this open label extension study (extension to study DK143WS) is to evaluate the safety of Biatain Ibu during 6 -12 weeks of exposure and during a 40 - 46 weeks safety follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient has participated in study DK143WS\n* The patient is able to understand the treatment and is willing to comply with the treat-ment regimen.\n* The patient is willing and able to give written informed consent\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Concomitant participation in other studies'}, 'identificationModule': {'nctId': 'NCT00628004', 'briefTitle': 'Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'An Open Label Extension Study (to Study DK143WS) Evaluating the Safety and Long-term Safety Follow-up of Biatain Ibu in Painful Chronic Venous Leg Ulcers', 'orgStudyIdInfo': {'id': 'DK144WS'}, 'secondaryIdInfos': [{'id': 'DK144WS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Device: Biatain Ibu']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Device: Local best practice']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment', 'description': 'No treatment as wound was healed'}], 'interventions': [{'name': 'Biatain Ibu', 'type': 'DEVICE', 'otherNames': ['Coloplast Biatain Ibu'], 'description': 'Biatain Ibu non-adhesive (Coloplast A/S), a polyurethane foam dressing with an elastic semi-permeable backing film with an added pain relieving medicinal substance ibuprofen (Albermarle Inc.), size 15x15 cm. The product is CE marked.', 'armGroupLabels': ['1']}, {'name': 'Local best practice', 'type': 'DEVICE', 'description': 'N/A - since intervention is "local best practice"', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus Universitetshospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense Universitets Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Georg-August-Universität Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '28942', 'city': 'Fuenlabrada', 'country': 'Spain', 'facility': 'Hospital de Fuenlabrada', 'geoPoint': {'lat': 40.28419, 'lon': -3.79415}}], 'overallOfficials': [{'name': 'Karsten Fogh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}