Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-01-06 @ 1:22 AM
Study NCT ID:
NCT00627094
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2008-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dkkg@coloplast.com', 'phone': '+4549113557', 'title': 'Scientific Manager', 'organization': 'Coloplast'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Biatain Ibu', 'description': 'Biatain foam dressing containing ibuprofen', 'otherNumAtRisk': 60, 'otherNumAffected': 4, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Biatain', 'description': 'Biatain foam dressing without ibuprofen', 'otherNumAtRisk': 60, 'otherNumAffected': 6, 'seriousNumAtRisk': 60, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Contact dermatitis in the peri-ulcer skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased pain in study ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blisters at the edge of the dressing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection in study ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalisation due to gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}, {'units': 'Total Number of scores day 1-5', 'counts': [{'value': '468', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biatain Ibu', 'description': 'Biatain foam dressing containing ibuprofen'}, {'id': 'OG001', 'title': 'Biatain', 'description': 'Biatain foam dressing without ibuprofen - control'}], 'classes': [{'title': 'No Pain Relief', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Slight Pain Relief', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Moderate Pain Relief', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'A lot Pain Relief', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Complete Pain Relief', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0438', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.73', 'ciLowerLimit': '1.02', 'ciUpperLimit': '2.96', 'pValueComment': 'In order to obtain 90% power to show superiority of Biatain Ibu compared to Biatain, a sample size of 60 pts per group (assuming a 15% drop-out rate) was found by simulating data from multi-nomial distributions over time.', 'groupDescription': 'The null hypothesis to be tested was that the distributions of categorical responses were the same.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Result based on ITT population (evening). PP-analysis show a strong tendency (not significant) in favour of Biatain Ibu supporting the ITT-analysis'}], 'paramType': 'NUMBER', 'timeFrame': 'Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning)', 'description': 'The distribution of pain relief assesment during day 1 to 5. The pain relief was registrated on 5-point verbal rating scales (evening/morning) from day 1 to day 5 after start of treatment.', 'unitOfMeasure': 'percentage of scores within category', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Total Number of scores day 1-5', 'denomUnitsSelected': 'Total Number of scores day 1-5', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Pain Intensity (PI) Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biatain Ibu', 'description': 'Biatain foam dressing containing Ibuprofen'}, {'id': 'OG001', 'title': 'Biatain', 'description': 'Biatain Foam dressing without ibuprofen - control'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline in Pain Intensity (PI) on day 4 evening', 'description': 'Pain intensity (PI) assesment performed daily during the days 1-5. Pain intensity assesment performed on a 11 point numerical box scale: 0 was no pain and 10 was worst possible pain. A positive outcome measure value (PI (baseline) - PI (day 4 evening)) means that PI has decreased since baseline and thus reflects clinical improvement (patients suffer less from pain).', 'unitOfMeasure': 'Change in PI since baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP-population (The PP population consisted of all randomized subjects that fulfilled the inclusion/exclusion criteria and which did not violate the protocol in a serious way day 1-5) - Evaluation performed on un-blinded data before database lock.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ulcer Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biatain Ibu', 'description': 'Biatain foam dressing containing Ibuprofen'}, {'id': 'OG001', 'title': 'Biatain', 'description': 'Biatain Foam dressing without ibuprofen - control'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '82', 'groupId': 'OG000'}, {'value': '50', 'spread': '60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Change from baseline to end of trial (day 43)', 'description': 'Relative change from baseline in ulcer area using last observation carried forward. A positive outcome value Means that wound size has decreased and thus reflects wound healing (clinical improvement)', 'unitOfMeasure': 'Relative change from baseline in percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biatain Ibu', 'description': 'Biatain foam dressing containing Ibuprofen'}, {'id': 'OG001', 'title': 'Biatain', 'description': 'Biatain Foam dressing without ibuprofen - control'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Continuously from start of treatment to end of trial (day 43)', 'description': 'Number of Adverse events reported which were evaluated to be related or possible related to the device', 'unitOfMeasure': 'Number of AE', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Biatain Ibu', 'description': 'Biatain foam dressing containing Ibuprofen'}, {'id': 'FG001', 'title': 'Biatain', 'description': 'Biatain Foam dressing without ibuprofen - control'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'ulcer healed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Biatain Ibu', 'description': 'Biatain foam dressing containing ibuprofen'}, {'id': 'BG001', 'title': 'Biatain', 'description': 'Biatain foam dressing without ibuprofen - control'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '71.6', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '69.5', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '70.6', 'spread': '12.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'YEARS', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-17', 'studyFirstSubmitDate': '2008-02-20', 'resultsFirstSubmitDate': '2015-09-03', 'studyFirstSubmitQcDate': '2008-02-20', 'lastUpdatePostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-14', 'studyFirstPostDateStruct': {'date': '2008-02-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Relief', 'timeFrame': 'Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning)', 'description': 'The distribution of pain relief assesment during day 1 to 5. The pain relief was registrated on 5-point verbal rating scales (evening/morning) from day 1 to day 5 after start of treatment.'}], 'secondaryOutcomes': [{'measure': 'Pain Intensity (PI) Change', 'timeFrame': 'Change from baseline in Pain Intensity (PI) on day 4 evening', 'description': 'Pain intensity (PI) assesment performed daily during the days 1-5. Pain intensity assesment performed on a 11 point numerical box scale: 0 was no pain and 10 was worst possible pain. A positive outcome measure value (PI (baseline) - PI (day 4 evening)) means that PI has decreased since baseline and thus reflects clinical improvement (patients suffer less from pain).'}, {'measure': 'Change From Baseline in Ulcer Area', 'timeFrame': 'Change from baseline to end of trial (day 43)', 'description': 'Relative change from baseline in ulcer area using last observation carried forward. A positive outcome value Means that wound size has decreased and thus reflects wound healing (clinical improvement)'}, {'measure': 'Adverse Events', 'timeFrame': 'Continuously from start of treatment to end of trial (day 43)', 'description': 'Number of Adverse events reported which were evaluated to be related or possible related to the device'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Leg Ulcers']}, 'descriptionModule': {'briefSummary': 'The objective of this investigation is to demonstrate the effectiveness and safety of Biatain Ibu non-adhesive foam dressing compared to Biatain non-adhesive foam dressing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>= 18 years of age\n* Chronic venous leg ulcer on the lower leg\n* Ulcer duration \\>= 8 weeks\n* Pain intensity in study ulcer at least 4 on an 11-point numerical box scale (NBS): 0= no pain, 10= worst possible pain\n* Exudate level moderate to high\n* Ulcer size min 1.6 cm and max 11 cm in any direction\n* Ankle/brachial index \\>= 0.8\n* Treated with moist wound healing during the past 2 weeks prior to inclusion\n* Adequate compression therapy during the past 2 weeks prior to inclusion\n* The patient is cognitive capable of evaluating his/her pain relief and pain intensity\n* The patient is able to understand the treatment and is willing to comply with the treatment regimen.\n* The patient is able to complete the patient diary\n* The patient is willing and able to give written informed consent\n\nExclusion Criteria:\n\n* Painful ulcers that have been treatment resistant to analgesics for the past 6 months or more\n* Pregnant or lactating women\n* Known and verified hypersensitivity to any content of the products used in this investigation\n* Local infection (bacterial imbalanced wound) in the study ulcer\n* Clinical infection in the study ulcer\n* Diseases: Vasculitis, erysipelas and cellulitis of the peri-ulcer skin\n* The investigator considers the patient not eligible\n* Diseases and conditions where ibuprofen or other analgesics are contraindicated (including known hypersensitivity to Aspirin (acetylsalicylic acid) or other analgesics, especially associated with a history of asthma, rhinitis or urticaria)\n* Diabetes\n* Use of per need medication for the past 3 days\n* Concomitant treatment with systemic antibiotics other than nitrofurantoin\n* Concomitant treatment with systemic corticosteroids (more than 10 mg/day prednisolon or equivalent) or other immunosuppressants within 1 month prior to inclusion\n* Concomitant treatment with cancer chemotherapeutics\n* Concomitant participation in other studies\n* Previous participation in this study'}, 'identificationModule': {'nctId': 'NCT00627094', 'briefTitle': 'Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'A Randomised, Controlled and Double-blind Clinical Investigation on the Effectiveness and Safety of a Foam Dressing Biatain Ibu Non-adhesive vs. Biatain Non-adhesive, in Painful Chronic Venous Leg Ulcers', 'orgStudyIdInfo': {'id': 'DK143WS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biatain Ibu', 'description': 'Biatain Ibu', 'interventionNames': ['Device: Biatain Ibu']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Biatain', 'description': 'Biatain', 'interventionNames': ['Device: Biatain']}], 'interventions': [{'name': 'Biatain', 'type': 'DEVICE', 'otherNames': ['Coloplast Biatain'], 'description': 'A standard polyurethane foam dressing Biatain non-adhesive (Coloplast A/S) with an elastic semi-permeable backing film, size 15x15 cm. The product is CE marked.', 'armGroupLabels': ['Biatain']}, {'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': ['Biatain Ibu']}]}, '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': '62000', 'city': 'Arras', 'country': 'France', 'facility': 'CHU de Brest', 'geoPoint': {'lat': 50.29301, 'lon': 2.78186}}, {'zip': '54035', 'city': 'Nancy', 'country': 'France', 'facility': 'CHU de Nancy - Hôpital Fournier', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'Department for Dermatology, University School of Medicine', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Georg-August-Universität Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '30449', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Klinik für Dermatologie und Venerologie', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '66421', 'city': 'Homburg/Saar', 'country': 'Germany', 'facility': 'Universitätsklinikum des Saarlandes'}, {'zip': '58511', 'city': 'Lüdenscheid', 'country': 'Germany', 'facility': 'Dr. Renzo Bause Praxis', 'geoPoint': {'lat': 51.21977, 'lon': 7.6273}}, {'zip': '15831', 'city': 'Mahlow', 'country': 'Germany', 'facility': 'Fachartzpraxis für Dermatologie, Allergologie, Lasermedizin', 'geoPoint': {'lat': 52.36017, 'lon': 13.40954}}, {'zip': '36201', 'city': 'Vigo', 'state': 'Pontevedra', 'country': 'Spain', 'facility': 'C.S. SERGAS Rosalía de Castro - Enfermero', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'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'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}