Nctid:
NCT06221241
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009437", "term"=>"Neuralgia"}, {"id"=>"D000003929", "term"=>"Diabetic Neuropathies"}], "ancestors"=>[{"id"=>"D000010523", "term"=>"Peripheral Nervous System Diseases"}, {"id"=>"D000009468", "term"=>"Neuromuscular Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000010146", "term"=>"Pain"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D000048909", "term"=>"Diabetes Complications"}, {"id"=>"D000003920", "term"=>"Diabetes Mellitus"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}], "browseLeaves"=>[{"id"=>"M12381", "name"=>"Neuralgia", "asFound"=>"Neuropathic Pain", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M7124", "name"=>"Diabetic Neuropathies", "asFound"=>"Diabetic Peripheral Neuropathic Pain", "relevance"=>"HIGH"}, {"id"=>"M13432", "name"=>"Peripheral Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M12411", "name"=>"Neuromuscular Diseases", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"M7115", "name"=>"Diabetes Mellitus", "relevance"=>"LOW"}, {"id"=>"M26004", "name"=>"Diabetes Complications", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000069583", "term"=>"Pregabalin"}], "ancestors"=>[{"id"=>"D000000700", "term"=>"Analgesics"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000000927", "term"=>"Anticonvulsants"}, {"id"=>"D000002121", "term"=>"Calcium Channel Blockers"}, {"id"=>"D000049990", "term"=>"Membrane Transport Modulators"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000077264", "term"=>"Calcium-Regulating Hormones and Agents"}, {"id"=>"D000014151", "term"=>"Anti-Anxiety Agents"}, {"id"=>"D000014149", "term"=>"Tranquilizing Agents"}, {"id"=>"D000002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D000011619", "term"=>"Psychotropic Drugs"}], "browseLeaves"=>[{"id"=>"M476", "name"=>"Pregabalin", "asFound"=>"1 hour", "relevance"=>"HIGH"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M4246", "name"=>"Anticonvulsants", "relevance"=>"LOW"}, {"id"=>"M5398", "name"=>"Calcium, Dietary", "relevance"=>"LOW"}, {"id"=>"M5381", "name"=>"Calcium", "relevance"=>"LOW"}, {"id"=>"M5384", "name"=>"Calcium Channel Blockers", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M16905", "name"=>"Anti-Anxiety Agents", "relevance"=>"LOW"}, {"id"=>"M14474", "name"=>"Psychotropic Drugs", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Channel Blockers", "abbrev"=>"ChanBlk"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Anticonvulsants", "abbrev"=>"AntiConv"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Psychotropic Drugs", "abbrev"=>"PsychDr"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Bone Density Conservation Agents", "abbrev"=>"BDCA"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>220}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-03-25", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04", "completionDateStruct"=>{"date"=>"2025-04-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-04-14", "studyFirstSubmitDate"=>"2024-01-03", "studyFirstSubmitQcDate"=>"2024-01-14", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-16", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-03-14", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Change of the Average Daily Pain Score (ADPS) from baseline to Week 12. [ADPS is the weekly average pain score based on the 11-point numeric rating scale (NRS)]", "timeFrame"=>"baseline，Week 12", "description"=>"Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0\\[no pain\\] to 10 \\[worst possible pain\\]"}], "secondaryOutcomes"=>[{"measure"=>"Change of the Average Daily Pain Score (ADPS) from baseline to Week 5. [ADPS is the weekly average pain score based on the 11-point numeric rating scale (NRS)]", "timeFrame"=>"baseline，Week 5", "description"=>"Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0\\[no pain\\] to 10 \\[worst possible pain\\]"}, {"measure"=>"Adverse Events", "timeFrame"=>"baseline，Week 12"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Diabetic Peripheral Neuropathic Pain"]}, "descriptionModule"=>{"briefSummary"=>"A Phase 2, Multicenter, Randomized, Double-blind, Placebo and Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX000623 in Participants with Diabetic Peripheral Neuropathic Pain", "detailedDescription"=>"Evaluate the Efficacy and Safety of JMKX000623 in Participants with Diabetic Peripheral Neuropathic Pain"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Able to understand the procedures of this trial and provide written informed consent voluntarily;\n2. Age ≥ 18 years, male or female;\n3. Diagnosed with Diabetic Peripheral Neuropathic Pain for ≥ 24 weeks;\n4. Visual Analog Scale (VAS) of 40-90 mm, and ADPS of 4-9;\n5. HbA1c ≤ 9.0% and on a stable antidiabetic medication regimen for ≥ 4 weeks.\n\nExclusion Criteria:\n\n1. With other peripheral neuropathies or painful diseases except for Diabetic Peripheral Neuropathic Pain;\n2. Possibly allergic to the active ingredients or excipients of JMKX000623, pregabalin and acetaminophen, or history of ≥ 3 allergens, or with ongoing allergic conditions;\n3. Received analgesic medications within 4 weeks prior to screening, or scheduled to use other analgesic medications during the trial;\n4. Known treatment failure on pregabalin or gabapentin;"}, "identificationModule"=>{"nctId"=>"NCT06221241", "briefTitle"=>"Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic Pain", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Jemincare"}, "officialTitle"=>"A Phase 2, Multicenter, Randomized, Double-blind, Placebo and Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX000623 in Participants With Diabetic Peripheral Neuropathic Pain", "orgStudyIdInfo"=>{"id"=>"JMKX0623-201"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"JMKX000623", "description"=>"JMKX000623 for 12 weeks", "interventionNames"=>["Drug: JMKX000623", "Drug: Placebo"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Pregabalin", "description"=>"Pregabalin for 12 weeks", "interventionNames"=>["Drug: Pregabalin", "Drug: Placebo"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo", "description"=>"placebo for 12 weeks", "interventionNames"=>["Drug: Placebo"]}], "interventions"=>[{"name"=>"JMKX000623", "type"=>"DRUG", "description"=>"tablets for oral administration.", "armGroupLabels"=>["JMKX000623"]}, {"name"=>"Pregabalin", "type"=>"DRUG", "description"=>"capsules for oral administration.", "armGroupLabels"=>["Pregabalin"]}, {"name"=>"Placebo", "type"=>"DRUG", "description"=>"matched to JMKX000623 and Pregabalin", "armGroupLabels"=>["JMKX000623", "Placebo", "Pregabalin"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"100034", "city"=>"Beijing", "state"=>"Beijing", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Lei Xing, PM", "role"=>"CONTACT", "email"=>"xinglei@jemincare.com", "phone"=>"010-66119025"}, {"name"=>"Xiaohui Guo, MD", "role"=>"CONTACT", "email"=>"xinglei@jemincare.com", "phone"=>"010-66119025"}], "facility"=>"Peking University First Hospital", "geoPoint"=>{"lat"=>39.9075, "lon"=>116.39723}}], "centralContacts"=>[{"name"=>"Lei Xing, PM", "role"=>"CONTACT", "email"=>"xinglei@jemincare.com", "phone"=>"010-66119025"}, {"name"=>"Xiaohui Guo, MD", "role"=>"CONTACT", "phone"=>"010-66119025"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Jemincare", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
