{ "FullStudy":{ "Rank":218067, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513161", "OrgStudyIdInfo":{ "OrgStudyId":"TRK-820_PRU_III_2007" }, "Organization":{ "OrgFullName":"SK Chemicals Co., Ltd.", "OrgClass":"INDUSTRY" }, "BriefTitle":"Efficacy and Safety Study of TRK-820 to Treat Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis", "OfficialTitle":"A 14 Day, Multi-center, Randomized, Double Blinded, Placebo-controlled, Parallel Group, Fixed Dose, Phase III Clinical Trial to Assess the Efficacy and Safety of TRK-820 in Treating Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis", "Acronym":"TRK-820" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"April 2008" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2009", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"October 2009", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"November 23, 2010", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 19, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 20, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"SK Chemicals Co., Ltd.", "LeadSponsorClass":"INDUSTRY" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Toray Industries, Inc", "CollaboratorClass":"INDUSTRY" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to determine whether nalfurafine hydrochloride is effective and safe in the treatment for conventional-treatment-resistant pruritus in patients receiving hemodialysis." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis" ] }, "KeywordList":{ "Keyword":[ "pruritus" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Factorial Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"104", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"TRK-820 5μg", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Taking TRK-820 5μg(two 2.5μg capsules) by oral route once daily for 14 days", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: nalfurafine hydrochloride (TRK-820)" ] } },{ "ArmGroupLabel":"TRK-820 2.5μg", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Taking TRK-820 2.5μg(one 2.5μg capsule & one placebo capsule)by oral route once daily for 14 days", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: nalfurafine hydrochloride (TRK-820)" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Taking Placebo(two placebo capsule) by oral route once daily for 14 days", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"nalfurafine hydrochloride (TRK-820)", "InterventionDescription":"Soft capsule containing 2.5ug nalfurafine hydrochloride. Start with 2.5ug of oral administraion once daily, and can be increased up to 5ug if necessary.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "TRK-820 2.5μg", "TRK-820 5μg" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in pruritus degree measured by VAS(Visual Analogue Scale) score", "PrimaryOutcomeTimeFrame":"4 weeks (2 weeks measurement with only conventional treatment + 2 weeks measurement with conventional treatment & investigational products)" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Changes in Shiratori's severity scores assessed by the subject.", "SecondaryOutcomeTimeFrame":"4 weeks (2 weeks measurement with only conventional treatment + 2 weeks measurement with conventional treatment & investigational products)" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\n[At the time of obtaining the consent form]\n\nChronic renal failure patients who regularly receive hemodialysis three times a week and are not likely to have a serious treatment change or acute symptoms during the study period\n\nPatients who received both of the drug pruritus treatments in section 1 and 2 below within one year before the day of singing consent form\n\nSystemic therapy of more than two consecutive weeks depending on antihistamine or antiallergic drugs falling under \"prescription drugs with indication of pruritus\" (oral drugs, injections, etc.)\nLocal therapy depending on \"prescription drugs with indication of pruritus\" (ointment, etc.) or a moisturizer prescribed by a doctor (topical preparation, etc.)\nPatients for whom all the conventional pruritus treatments in section (2) are not enough\nPatients aged 20 years or older at time of signing the consent form\n\n[At the time of enrollment]\n\nPatients whose VAS scores are measured both after breakfast and dinner for five days or more of the last 7 days of the predose observation period and whose mean of whichever the higher VAS scores after breakfast or dinner is ≥50 mm\nPatients whose whichever the higher VAS score after breakfast or dinner for the last 7 days during the preliminary observation day (measured VAS score if one is missing) is more than ≥20 mm for five days or more\nPatients who are judged to have pruritus both during the day and at night for more than two days based on the Shiratori's severity criteria assessed by the subject at days of fifth and sixth hemodialysis and the day of hemodialysis after the completion of the predose observation period, and whose whichever the higher pruritis score measured during the day or at night is 3 (moderate) for two days or more\n\nExclusion Criteria:\n\nPatients with malignant tumor\nPatients with depression, schizophrenia or dementia as complications\nPatients who currently have Child-pugh class B or C hepatic cirrhosis as complications\nPatients with clinically significant hepatic or cardiovascular diseases which cannot be controlled by diet or drug therapy\nPatients who currently have the following heart diseases: life-threatening arrhythmia; unstable angina or myocardiac infarction within 6 months; PCI or CABG within 6 months; NYHA class III or IV congestive heart failure\nPatients with atopic dermatitis or chronic urticaria as complications\nPatients who are allergic to opioid drugs\nPatients with dependence on drug or alcohol\nPatients who received phototherapy for pruritus within one month before signing the consent form\nPatients who participated in the study of TRK-820 and received the study drug or who were already enrolled in this study\nPatients who participated in other clinical studies (including the ones using artificial kidney and medical equipment), and received the study drug or treatment with clinical equipment within one month before signing the consent form\nPregnant women, lactating women and patients of childbearing potential who do not use contraceptive methods\nPatients who cannot report VAS scores by their own for any reason at the principal investigator or study personnel's discretion\nPatients whose complications or history can impact the results of this study at the principal investigator or subinvestisator's discretion\nOther patients who are not proper to participate in this study at the principal investigator or study personnel's discretion", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"20 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Suhng Gwon Kim, MD, PhD", "OverallOfficialAffiliation":"Seoul National University Hospital", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"SKchemicals Investigational Site", "LocationCity":"Seoul", "LocationCountry":"Korea, Republic of" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000011537", "ConditionMeshTerm":"Pruritus" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000012871", "ConditionAncestorTerm":"Skin Diseases" },{ "ConditionAncestorId":"D000012877", "ConditionAncestorTerm":"Skin Manifestations" },{ "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M12979", "ConditionBrowseLeafName":"Pruritus", "ConditionBrowseLeafAsFound":"Pruritus", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14257", "ConditionBrowseLeafName":"Skin Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14263", "ConditionBrowseLeafName":"Skin Manifestations", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }