Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT01937156
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2013-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017829', 'term': 'Granisetron'}], 'ancestors': [{'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 313}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-10', 'studyFirstSubmitDate': '2013-09-03', 'studyFirstSubmitQcDate': '2013-09-03', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects achieving Complete Control (CC) of CINV from the first administration until 24 hour after the last administration of ME or HE multi-day chemotherapy', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chemotherapy-induced Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of SP-01 in chemotherapy-induced nausea and vomiting (CINV) associated with the administration of moderately or highly emetogenic (ME or HE) multi-day chemotherapy，which will provide scientific and reliable clinical data in the drug registration in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged ≥ 18years\n* Histologically and/or cytologically confirmed cancer\n* The physical status score ECOG ≤ 2\n* Life expectancy of ≥3 months\n* Will receive multi-day ME/HE chemotherapy (≥2 days) with the emetogenic potential of level 3-5\n* In accordance with the indication of chemotherapy and basic requirements;\n\n * Peripheral Haematology: Hb ≥ 9.0 g/dL, absolute neutrophil count ≥ 1.5×10e9/L, platelet count ≥ 80×10e9/L\n * Blood biochemistry: Total bilirubin \\< 1.25×ULN, ALT and AST ≤ 2.5×ULN; if liver metastasis, ALT and AST \\< 5×ULN, Creatinine ≤ 1×ULN, basic normal serum electrolyte (Na, Ka, Cl, Ca)\n * Other important organs function normally\n* Subjects voluntarily participate and signed the informed consent form'}, 'identificationModule': {'nctId': 'NCT01937156', 'briefTitle': 'A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solasia Pharma K.K.'}, 'officialTitle': 'A Randomized, Active-control, Double-blind, Double-dummy, Parallel-group, Multi-center Study to Assess the Efficacy and Safety of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting Associated With the Administration of Moderately or Highly Emetogenic (ME or HE) Multi-day Chemotherapy', 'orgStudyIdInfo': {'id': 'SP-0103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SP-01', 'interventionNames': ['Drug: SP-01 (Granisetron Transdermal Delivery System)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Granisetron Hydrochloride Tablet', 'interventionNames': ['Drug: Granisetron Hydrochloride Tablet']}], 'interventions': [{'name': 'SP-01 (Granisetron Transdermal Delivery System)', 'type': 'DRUG', 'description': 'SP-01 will be applied to the upper arm 24-48 hours before the start of chemotherapy, and left in place for 7 days.', 'armGroupLabels': ['SP-01']}, {'name': 'Granisetron Hydrochloride Tablet', 'type': 'DRUG', 'description': 'Granisetron hydrochloride 1 mg tablets will be administered 1 hour before administration of chemotherapy at the first time, then taken 12 hours after the first dose later; 2 mg/day bid, for ≥ 2 days.', 'armGroupLabels': ['Granisetron Hydrochloride Tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The 81st Hospital of P.L.A.', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Shukui Qin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The 81st hospital of P.L.A.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solasia Pharma K.K.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Proswell Medical Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}