Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-02-25 @ 9:48 PM
Study NCT ID:
NCT02337569
Status:
COMPLETED
Last Update Posted:
2019-04-17
First Post:
2015-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Double-Blind, Placebo Controlled Study of NPC-02 in Patients With Zinc Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2015-01-09', 'studyFirstSubmitQcDate': '2015-01-12', 'lastUpdatePostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change amount of serum zinc concentration between starting and 8 weeks after dosing', 'timeFrame': '8 weeks'}]}, 'conditionsModule': {'conditions': ['Zinc Deficiency']}, 'referencesModule': {'references': [{'pmid': '31392541', 'type': 'DERIVED', 'citation': 'Katayama K, Hosui A, Sakai Y, Itou M, Matsuzaki Y, Takamori Y, Hosho K, Tsuru T, Takikawa Y, Michitaka K, Ogawa E, Miyoshi Y, Ito T, Ida S, Hamada I, Miyoshi K, Kodama H, Takehara T. Effects of Zinc Acetate on Serum Zinc Concentrations in Chronic Liver Diseases: a Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial and a Dose Adjustment Trial. Biol Trace Elem Res. 2020 May;195(1):71-81. doi: 10.1007/s12011-019-01851-y. Epub 2019 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate efficacy and safety of NPC-02 in patients with Zinc Deficiency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe serum zinc concentrations are under the normal level before registration\n\nExclusion Criteria:\n\n1. Heavy hepatitis\n2. Malignant tumor\n3. Severe heart disease, hematological disorder, kidney disease and pancreatic disease, etc.\n4. The serum albumin under 2.8 g/dL\n5. Patient of allergy and hyperesthesia to zinc containing medicine manufacturing (including supplement)\n6. Patient who was taking a medicine including the zinc (including supplement) within 12 weeks before registration\n7. Pregnant, suspected pregnant, lactating, patients who wish to have a child\n8. Patient who participated in other clinical trials within 12 weeks before registration\n9. Unsuitable as a target of this clinical trial judged by doctor'}, 'identificationModule': {'nctId': 'NCT02337569', 'briefTitle': 'A Randomized, Double-Blind, Placebo Controlled Study of NPC-02 in Patients With Zinc Deficiency', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nobelpharma'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo Controlled Study of NPC-02 in Patients With Zinc Deficiency', 'orgStudyIdInfo': {'id': 'NPC-02-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NPC-02', 'description': 'Oral dose', 'interventionNames': ['Drug: NPC-02']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral dose', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'NPC-02', 'type': 'DRUG', 'armGroupLabels': ['NPC-02']}, {'name': 'Placebos', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Medical Center for Cancer and Cardiovascular Diseases', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nobelpharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}