Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-01-05 @ 5:14 PM
Study NCT ID:
NCT00638495
Status:
COMPLETED
Last Update Posted:
2010-02-01
First Post:
2008-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C111212', 'term': 'TRK 820'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-28', 'studyFirstSubmitDate': '2008-03-12', 'studyFirstSubmitQcDate': '2008-03-18', 'lastUpdatePostDateStruct': {'date': '2010-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in VAS value (based on morning or evening scores, whichever larger, during the treatment period [4th week])', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pruritus With Chronic Liver Disease']}, 'descriptionModule': {'briefSummary': 'The efficacy and safety of TRK-820 are to be evaluated in the treatment of intractable pruritus in patients with Chronic Liver Disease by administering 2.5, 5 and 10 microg of this drug or placebo for 28 days in four groups with a design of randomized, double-blind, parallel-group comparison. In addition, the plasma concentrations of TRK-820 and its primary metabolites are to be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chronic Liver Disease is present; and the patient's general condition is judged by the physician to be stable with no prospect of an abrupt change in pathophysiology.\n* It can be confirmed by either of the following that treatment of pruritus with antihistamines or antiallergics has not been adequately effective in such patients:\n\nExclusion Criteria:\n\n* Malignant tumors\n* Depression, integration dysfunction syndrome (schizophrenia), or dementia\n* Hepatic encephalopathy, or hepatic cirrhosis in which ascites or esophageal or gastric aneurysm cannot be controlled\n* Alcoholic liver disease\n* Atopic dermatitis, chronic urticaria, or other skin disease producing generalized pruritus that is judged by the physician to affect the assessment of pruritus associated with Chronic Liver Disease in this study\n* Allergy to opioid drugs\n* Drug dependence or alcohol dependence\n* Chronic renal failure"}, 'identificationModule': {'nctId': 'NCT00638495', 'briefTitle': 'Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -', 'organization': {'class': 'INDUSTRY', 'fullName': 'Toray Industries, Inc'}, 'officialTitle': 'Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -', 'orgStudyIdInfo': {'id': '820HPC01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Nalfurafine Hydrochloride (TRK-820)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nalfurafine Hydrochloride (TRK-820)', 'type': 'DRUG', 'otherNames': ['REMITCH'], 'description': 'TRK-820 2.5, 5 and 10 microg is to be administered orally once daily, after supper in principle, for 28 days.', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo is to be administered orally once daily, after supper in principle, for 28 days.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '279-8555', 'city': 'Urayasu', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Toray Industries, Inc', 'geoPoint': {'lat': 35.65879, 'lon': 139.90055}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Toray Industries, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Toray Industries, Inc', 'oldOrganization': 'Pharmaceutical Clinical Research Dept.'}}}}