Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-30 @ 3:32 AM
Study NCT ID:
NCT01063569
Status:
COMPLETED
Last Update Posted:
2013-03-20
First Post:
2010-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glucocorticoid Treatment in Addison's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000224', 'term': 'Addison Disease'}], 'ancestors': [{'id': 'D000309', 'term': 'Adrenal Insufficiency'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C007133', 'term': 'hydrocortisone hemisuccinate'}, {'id': 'D006854', 'term': 'Hydrocortisone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-19', 'studyFirstSubmitDate': '2010-01-26', 'studyFirstSubmitQcDate': '2010-02-04', 'lastUpdatePostDateStruct': {'date': '2013-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morning (08-09) plasma ACTH', 'timeFrame': 'Time 0, months 2, 3, 5, 7 and 8'}], 'secondaryOutcomes': [{'measure': 'Health-Related Quality of Life; evaluated by SF-36 vitality scores and AddiQoL scores', 'timeFrame': 'At time 0 and months 2,3,5,7 and 8'}, {'measure': "Sleep; evaluated by Pittsburgh Sleep Quality Index (PSQI), and 7-days' Actigraph registration combined with self-reported sleep diary", 'timeFrame': 'PSQI: 0 and months 2,3,5,7 and 8; Actigraph/sleep diary: months 2 and 7'}, {'measure': '24h cortisol profiles in serum and saliva', 'timeFrame': 'months 2 and 7'}, {'measure': 'S-glucose, 24 h profile', 'timeFrame': 'months 2 and 7'}, {'measure': 'Insulin sensitivity assessed by euglycemic clamp', 'timeFrame': 'Months 2 and 7'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Addison's disease", 'Glucocorticoid treatment', 'Continuous subcutaneous hydrocortisone infusion', 'CSHI', 'Quality of Life', 'Sleep'], 'conditions': ["Addison's Disease"]}, 'descriptionModule': {'briefSummary': "Addison's disease is a rare condition which in most cases is caused by autoimmune destruction of the adrenals, leading to deficiency of cortisol, aldosterone and adrenal androgens. Unrecognized the disease is life threatening, but with proper treatment patients can live near normal lives.\n\nThe conventional glucocorticoid replacement therapy renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. Glucocorticoid replacement therapy is technically feasible by continuous subcutaneous hydrocortisone infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This study aims to further evaluate CSHI treatment in terms of metabolic effects, effects on health-related quality-of-life and sleep in an 8 months randomised open label clinical trial with crossover design."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with verified Addison's disease on stable treatment.\n\nExclusion Criteria:\n\n* Insulin treated Diabetes Mellitus, cardiovascular disease,malignant disease, pregnancy.\n* Treatment with glucocorticoids or drugs that interfere with cortisol metabolism (antiepileptics, rifampicin, St. John's wart)."}, 'identificationModule': {'nctId': 'NCT01063569', 'briefTitle': "Glucocorticoid Treatment in Addison's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': "Glucocorticoid Treatment in Addison's Disease", 'orgStudyIdInfo': {'id': '3.2007.2343'}, 'secondaryIdInfos': [{'id': '2009-010917-61', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oral hydrocortisone', 'interventionNames': ['Drug: Cortef (hydrocortisone)']}, {'type': 'EXPERIMENTAL', 'label': 'Continous subcutaneous hydrocortisone infusion', 'interventionNames': ['Drug: Solu-Cortef (hydrocortisone)']}], 'interventions': [{'name': 'Solu-Cortef (hydrocortisone)', 'type': 'DRUG', 'otherNames': ['Solu-Cortef'], 'description': 'Continuous Subcutaneous Hydrocortisone infusion via insulin pump. Doses adjusted to body surface area.', 'armGroupLabels': ['Continous subcutaneous hydrocortisone infusion']}, {'name': 'Cortef (hydrocortisone)', 'type': 'DRUG', 'otherNames': ['Cortef 5 mg'], 'description': 'Oral treatment 3 times a day. Weight adjusted doses.', 'armGroupLabels': ['Oral hydrocortisone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Kristian Løvås, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haukeland University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}