[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658934":3},{"organization":4,"outcomesModule":7,"designInfo":78,"detailedDescription":28,"studyPopulation":28,"armGroups":87,"interventions":104,"overallOfficials":28,"centralContacts":122,"locations":128,"responsibleParty":148,"collaborators":28,"id":150,"slug":151,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":28,"eligibilityCriteria":156,"healthyVolunteers":152,"sex":157,"minAge":158,"maxAge":28,"enrollmentInfo":159,"targetDuration":28,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":28,"overallStatus":131,"whyStopped":28,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"Zhejiang Hanmai Pharmaceutical Technology Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":28},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in Average Daily Pain Score (ADPS)","Change from baseline in Average Daily Pain Score (ADPS). ADPS is collected from patient daily pain diary. The difference between YJ001 spray group and placebo group will be compared.","Week 12",{"measure":14,"description":15,"timeFrame":16},"Number of participants with clinically significant changes in safety parameters from baseline","Safety parameters including adverse events (AEs), laboratory tests, physical examination, vital signs and electrocardiogram (ECG). Clinically significant changes from baseline will be assessed at Week 52 during the open-label extension part (part two).","week 52",[18,22,26,30,33,37,40,44,47,50,54,56,59,63,65,69,71,75],{"measure":19,"description":20,"timeFrame":21},"Compared with the placebo group, the Change from baseline in Average Daily Pain Score (ADPS) at weeks 1-11 and 13 after treatment in the test group","ADPS is collected from the average daily pain NRA score based on diary card records. The difference between YJ001 spray group and placebo group will be compared","weeks 1-11 and 13",{"measure":23,"description":24,"timeFrame":25},"Compared with the positive control group, the change in Average Daily Pain Score（ADPS） from baseline to the 1-13 weeks after treatment in the test group;","ADPS is collected from the average daily pain NRA score based on diary card records.","weeks 1-13",{"measure":27,"description":28,"timeFrame":29},"The response rates of ADPS (the proportion of trial participants with weekly ADPS decrease of ≥30% and ≥50% relative to baseline) in the three groups at the 12 and 13 week after treatment",null,"weeks 12 and 13",{"measure":31,"description":28,"timeFrame":32},"The proportion of trial participants with ADPS scores less than 1 in the three groups at the 12 and 13 weeks after treatment","12 and 13 weeks",{"measure":34,"description":35,"timeFrame":36},"Change from baseline in Short-Form McGill Pain Questionnaire Verbal Analogue Scale (SF-MPQ-VAS) score","Short-Form McGill Pain Questionnaire Verbal Analogue Scale (SF-MPQ-VAS). The scale ranges from 0 to 10. Higher scores indicate worse pain. Change from baseline in SF-MPQ-VAS scores will be compared among the three groups at Week 12 and Week 13.","12th and 13th weeks",{"measure":38,"description":39,"timeFrame":36},"Change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) total score","Short-Form McGill Pain Questionnaire (SF-MPQ). Total score ranges from 0 to 45. Higher scores indicate worse pain. Change from baseline in SF-MPQ total scores will be compared among the three groups at Week 12 and Week 13.",{"measure":41,"description":42,"timeFrame":43},"At the 13th week after treatment, the overall impression of pain change (PGIC) among the three groups of trial participants","Patient Global Impression of Change (PGIC). The scale ranges from 1 to 7. Lower scores indicate better improvement in pain. PGIC scores will be compared among the three groups at Week 13.","13th week",{"measure":45,"description":46,"timeFrame":29},"Changes in weekly average sleep disturbance scores from baseline at weeks 12 and 13 after treatment in the three groups","Weekly average sleep disturbance score. The scale ranges from 0 to 10. Higher scores indicate worse sleep disturbance. Change from baseline in weekly average sleep disturbance scores will be compared among the three groups at Week 12 and Week 13.",{"measure":48,"description":49,"timeFrame":36},"Changes in Hospital Anxiety and Depression Scale (HADS) scores from baseline at the 12th and 13th weeks after treatment in the three groups","Hospital Anxiety and Depression Scale (HADS). Total score ranges from 0 to 42. Higher scores indicate greater anxiety and depression symptoms. Change from baseline in HADS scores will be compared among the three groups at Week 12 and Week 13.",{"measure":51,"description":52,"timeFrame":53},"Changes in Short Form-36 (SF-36) quality of life scale scores from baseline at 13 week after treatment in the three groups","Short Form-36 (SF-36) quality of life scale. Each domain score ranges from 0 to 100. Higher scores indicate better quality of life. Change from baseline in SF-36 scores will be compared among the three groups at Week 13.","13 week",{"measure":55,"description":28,"timeFrame":43},"At the 13th week after treatment, the percentage of participants using emergency medication and the total amount of emergency medication in the three groups",{"measure":57,"description":28,"timeFrame":58},"The incidence of adverse reactions leading to drug withdrawal or reduction in drug dosage in each group","weekly",{"measure":60,"description":61,"timeFrame":62},"Changes in SF-MPQ score and SF-MPQ-VAS score from baseline to the 52nd week after treatment","Short-Form McGill Pain Questionnaire (SF-MPQ). Total score ranges from 0 to 45. Higher scores indicate worse pain.\n\nShort-Form McGill Pain Questionnaire Verbal Analogue Scale (SF-MPQ-VAS). The scale ranges from 0 to 10. Higher scores indicate worse pain.","52 week",{"measure":64,"description":28,"timeFrame":58},"During the drug withdrawal follow-up period, changes in weekly SF-MPQ scores compared to the baseline period",{"measure":66,"description":67,"timeFrame":68},"Steady-state plasma concentration at 2 hours (C2h,ss) of YJ001","Steady-state plasma concentration at 2 hours (C2h,ss) of YJ001 spray in patients with diabetic peripheral neuropathic pain. C2h,ss will be measured at Weeks 21, 25 and 52.","weeks 21,25,52",{"measure":70,"description":28,"timeFrame":58},"During the drug withdrawal follow-up period, changes in weekly SF-MPQ-VAS compared to the baseline period",{"measure":72,"description":73,"timeFrame":74},"Steady-state plasma concentration at 6 hours (C2h,ss) of YJ001","Steady-state plasma concentration at 6 hours (C6h,ss) of YJ001 spray in patients with diabetic peripheral neuropathic pain. C6h,ss will be measured at Weeks 21, 25 and 52.","Weeks 21, 25 and 52",{"measure":76,"description":77,"timeFrame":74},"Steady-state minimum plasma concentration (Cmin,ss) of YJ001","Steady-state minimum plasma concentration (Cmin,ss) of YJ001 spray in patients with diabetic peripheral neuropathic pain. Cmin,ss will be measured at Weeks 21, 25 and 52.",{"allocation":79,"interventionModel":80,"interventionModelDescription":28,"primaryPurpose":81,"observationalModel":28,"timePerspective":28,"maskingInfo":82},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":83,"maskingDescription":28,"whoMasked":84},"DOUBLE",[85,86],"PARTICIPANT","INVESTIGATOR",[88,94,99],{"label":89,"type":90,"description":28,"interventionNames":91},"Placebo group","PLACEBO_COMPARATOR",[92,93],"Drug: YJ001 spray simulant","Drug: Crisugabalin Besilate Capsules simulant",{"label":95,"type":96,"description":28,"interventionNames":97},"experimental group","EXPERIMENTAL",[98,93],"Drug: YJ001 spray",{"label":100,"type":101,"description":28,"interventionNames":102},"positive control group","ACTIVE_COMPARATOR",[92,103],"Drug: Crisugabalin Besilate Capsules",[105,110,114,118],{"type":106,"name":107,"description":108,"armGroupLabels":109,"otherNames":28},"DRUG","YJ001 spray simulant","spray：0 mg\u002Fdose, once in the morning and once in the evening, 6 sprays per foot each time.",[89,100],{"type":106,"name":111,"description":112,"armGroupLabels":113,"otherNames":28},"YJ001 spray","spray：480 mg\u002Fdose, once in the morning and once in the evening, 6 sprays per foot each time.",[95],{"type":106,"name":115,"description":116,"armGroupLabels":117,"otherNames":28},"Crisugabalin Besilate Capsules","capsule：20mg per dose, twice a day",[100],{"type":106,"name":119,"description":120,"armGroupLabels":121,"otherNames":28},"Crisugabalin Besilate Capsules simulant","0mg per dose, twice a day",[89,95],[123],{"name":124,"role":125,"phone":126,"phoneExt":28,"email":127},"Jing Zhang","CONTACT","86-18602195085","zhangjing@zjhanmai.com",[129],{"facility":130,"status":131,"city":132,"state":133,"zip":134,"country":135,"countryCode":136,"cosmosGeoPoint":137,"geoPoint":142,"contacts":143},"Medical Institution","RECRUITING","Beijing","Haidian District","100089","China","CN",{"type":138,"coordinates":139},"Point",[140,141],116.39723,39.9075,{"lat":141,"lon":140},[144],{"name":145,"role":125,"phone":146,"phoneExt":28,"email":147},"Sheng D Fan","86-010-82266699","dsfan@sina.com",{"type":149,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100658934","phase-3-yj001-spray-for-diabetic-peripheral-neuropathic-pain-100658934",false,"NCT07859111","YJ001 Spray for Diabetic Peripheral Neuropathic Pain","Multicenter, Randomized, Double-blind, Double Simulation, Positive Drug and Placebo Parallel Control Phase III Clinical Trial And Open-label Extension Trial of YJ001 for Spray Use the Treatment of Diabetic Peripheral Neuropathic Pain","Inclusion Criteria:\n\n* Aged ≥18 years, of either gender\n* Diagnosed with type 1 or type 2 diabetes for at least 1 year\n* Diagnosed with diabetic peripheral neuropathic pain (DPNP, other tertiary hospitals' diagnostic certificates are acceptable), with pain duration ≥6 months, and the most painful area being the foot\n* Stable blood glucose control within 3 months prior to screening, i.e., glycated hemoglobin (HbA1c) ≤9.0% at screening. If the patient has been receiving hypoglycemic drug treatment at screening, stable treatment for at least 30 days is required;\n* If the patient has been receiving neurotrophic, circulation-improving, and metabolic drug treatments at screening, stable dosing for at least 30 days is required. If the patient has discontinued neurotrophic, circulation-improving, and metabolic drug treatments at screening, the duration of drug withdrawal must meet at least 7 drug half-lives as determined by the investigator;\n* If the patient has been receiving non-pharmacological treatments (including physiotherapy, massage, chiropractic treatment, psychological therapy, etc.) at screening, stable treatment for at least 12 weeks is required, and the treatment regimen must not be changed during the trial\n* If the patient has not been receiving stable non-pharmacological treatments (including physiotherapy, massage, chiropractic treatment, psychological therapy, etc.), non-pharmacological treatment must be discontinued for at least 1 week prior to screening, and no additional non-pharmacological treatments are planned to be added during the trial\n* Pain NRS score ≥4.0 and \\\u003C9.0 at screening\n* After the run-in period and before randomization, the trial participant meets all inclusion criteria and does not meet any exclusion criteria\n* The ADPS score during the run-in period \\[defined as the average of the daily pain NRS scores calculated based on the patient diary card records excluding the day of randomization\\] is ≥4, and the trial participant completes at least 10 pain assessments during the run-in period (excluding the day of randomization); - Both pain VAS scores at screening and during the 2-day visit before randomization are ≥40mm and \\\u003C90mm\n* Medication adherence to the study drug during the run-in period is 80-120% (inclusive)\n* The trial participant is willing and able to adhere to study visit schedules, treatment plans, laboratory tests, and other research procedures, agrees to participate in this trial, and signs a written informed consent form.\n\nParticipants in the second part of the trial must meet all the following criteria to be eligible for enrollment in the second part of this study.\n\n* Trial participants who have completed the double-blind treatment period;\n* Trial participants who are willing and capable of adhering to the study visit schedule, treatment plan, laboratory tests, and other research procedures.\n\nExclusion Criteria:\n\nExperiment Part One\n\n* Known or suspected to be allergic to or have serious adverse reactions to the active ingredients of Kligabalin Benzenesulfonate Capsules or any excipient ingredients, or allergic to or have serious adverse reactions to the ingredients of YJ001 Spray, the ingredients of YJ001 Spray Simulant, paracetamol, aspirin, salicylic acid or similar drugs of YJ001 (such as 5-aminosalicylic acid, sulfasalazine and salicylate);\n* Previous use of calcium channel modulators such as pregabalin, gabapentin, krigabalin, and melogabalin without improvement in pain (reported by the patient);\n* Those who have participated in the clinical study of YJ001 spray and received the study drug in the past;\n* According to the research, the test participants are in the acute stage of diabetes peripheral neuropathic pain, or need surgery for focal compression neuropathy, or have widespread systemic pain that will affect the evaluation of pain at the drug delivery site. According to the judgment of the researchers, the evaluation of pain at the drug delivery site will be affected; Or more severe in the hands or closer areas than in the feet; Or the test participants have pain caused by non diabetes peripheral neuropathy, such as active osteoarthritis, lumbar disc herniation, vitamin B deficiency (vitamin B12, folic acid), alcoholism, herpetic neuralgia, vasculitis, and serious depression, anxiety and other psychological diseases, which will affect the researchers' evaluation of diabetes peripheral neuropathic pain;\n* Participants who have severe peripheral vascular disease (such as intermittent claudication and lower limb arterial occlusion) during screening and are deemed unsuitable by the researchers to participate in the trial;\n* Abnormal skin conditions at the site of administration can affect the determination of test results, such as:\n\n  1. Those with a skin condition evaluation score greater than 2 points at the site of administration;\n  2. There is skin disease in the affected skin area, which affects the investigator's evaluation of diabetes related peripheral neuropathic pain, or the skin at the administration site is red, swollen, inflamed, damaged or other conditions that affect drug absorption, or according to the investigator's judgment, the test participants have tattoos that may interfere with the research purpose;\n  3. Patients with foot ulcers, infections and gangrene related to diabetes that have not recovered.\n* Malignant tumor patients, except for non metastatic skin basal cell carcinoma or squamous cell carcinoma that has received appropriate treatment or resection, or cervical cancer in situ;\n* Amputation of limbs other than the tips of fingers and toes;\n* Complicated with acute metabolic complications of diabetes, such as diabetes ketoacidosis or lactic acidosis or hyperosmolar hyperglycemia syndrome or diabetes hyperosmolar coma;\n* Within the 6 months prior to screening or during the introduction period, there has been one or more severe hypoglycemic events (referring to trial participants requiring assistance from others to obtain carbohydrates, glucagon, or other rescue measures);\n* When comparing and screening, the ADPS scores of the experimental participants during the introduction period decreased by ≥ 30%; When comparing and screening, the VAS scores of the trial participants decreased by ≥ 30% during the first 2 days of random visits;\n* Those who have been used within 2 weeks before screening or need to be combined with the following treatments during the planned trial: 1) transcutaneous electrical nerve stimulation (TENS), acupuncture and moxibustion treatment, infrared ray, laser, etc; 2) Local analgesics (such as NSAIDs, peppermint ointment, capsaicin patch, lidocaine patch, etc.) and opioid analgesics (such as morphine, tramadol, etc.);\n* During the trial period, it is planned to add and combine non pharmacological treatments such as physical therapy, massage, spinal acupressure therapy, psychological therapy, etc;\n* Before screening, within 7 drug half lives \\[14 hours for oral ibuprofen tablets and diclofenac sodium tablets, 5 days for naproxen tablets; 2 days for pregabalin capsules and gabapentin tablets, 7 days for krigabalin, 7 days for melogabalin, 4 days for carbamazepine; 2 days for venlafaxine tablets, 4 days for duloxetine, 12 days for amitriptyline, 2 weeks for traditional Chinese medicine\\], have received analgesic drugs \\[such as oral NSAIDs, calcium channel modulators (pregabalin, gabapentin, krigabalin, melogabalin) Participants in the trial of SNRIs drugs (such as duloxetine, venlafaxine, etc.), tricyclic antidepressants (such as amitriptyline, etc.), carbamazepine, oxcarbazepine, traditional Chinese medicine, etc.), or those who purchase and use the above drugs themselves during the trial, or those who need to add and use the above analgesic drugs for treatment during the trial (except for Clegabalin);\n* During screening, test participants were associated with the following active infections with abnormal clinical significance, including hepatitis B (HBV), hepatitis C (HCV), syphilis, and human immunodeficiency virus (HIV):\n\nActive hepatitis B is defined as: hepatitis B surface antigen positive and HBV-DNA detection value exceeding the upper limit of normal; Active hepatitis C is defined as: positive hepatitis C antibodies and HCV-RNA detection values exceeding the upper limit of normal; Positive for Treponema pallidum antibody (TP Ab) and positive for syphilis non-specific antibody titers; Known as a human immunodeficiency virus infection, or HIV antibody test result positive.\n\n* Abnormal liver and kidney function during screening: AST or ALT ≥ 2.5 times the upper limit of normal value, creatinine ≥ 1.5 times the upper limit of normal value; Or accompanied by thyroid dysfunction that cannot be controlled with stable drug doses, or clinically significant abnormalities in thyroid function test results during screening that require treatment initiation; Or combined with severe cardiovascular and cerebrovascular diseases (such as grade II or III heart block, NYHA heart failure classified as III-IV, myocardial infarction, acute stroke, etc.), unstable diseases (such as cerebral infarction, acute coronary syndrome), severe respiratory, blood and hematopoietic system diseases;\n* Those who have suicidal behaviors or suicidal tendencies in the past, or who are complicated with pernicious anemia, untreated hypothyroidism, or have other nervous system diseases (such as cognitive impairment), the researchers think that it may affect the evaluation of diabetes related peripheral neuropathic pain or affect the self rating, or the mental patients who are judged by the researchers to be not suitable for this trial;\n* Known history of drug abuse, drug dependence, and\u002For alcohol abuse within the past year \\[drinking more than 14 servings per week (1 serving is equivalent to 360mL of beer, 45mL of 40% alcohol strong liquor, or 150mL of wine)\\]; 19.Pregnant and lactating women; Male trial participants (including their female partners) and female trial participants with fertility, who have planned to have children or cannot guarantee the use of one or more contraceptive measures (commonly used contraceptive measures include sterilization surgery, intrauterine devices, birth control pills, condoms, etc.) within 3 months after the end of the trial from screening;\n* During the trial period, participants engaged in driving, operating complex machinery, or other potentially hazardous activities; 21.For patients with a bipedal administration area of less than 450cm\\^2\\[bipedal administration area (cm2)=0.00718 × W \\^ 0.425 × H \\^ 0.725 × 5% × 10000, where W is weight (kg) and H is height (cm)\\];\n* Screening participants who have participated in other interventional clinical trials within the previous 3 months;\n* Researchers believe that other situations are not suitable for participation in this experiment.\n\nThe second part of the experiment\n\n* Medication adherence \\\u003C 80% or \\> 120% in double-blind studies;\n* Major safety issues occur in the double-blind study or there are unresolved serious adverse events before the medication administration in the second part of this study;\n* Pregnant and lactating women; male trial participants (including their female partners) and female trial participants who are capable of reproduction, and who intend to conceive or cannot ensure the use of one or more contraceptive measures (common contraceptive measures include sterilization surgery, intrauterine devices, contraceptive pills, condoms, etc.) from the screening phase until 3 months after the end of the trial;\n* Other situations where the researcher deems it inappropriate to participate in this trial.","ALL","18 Years",{"count":160,"type":161},400,"ESTIMATED","INTERVENTIONAL",[164],"PHASE3","The goal of this clinical trial is to learn if YJ001 Spray works to treat diabetic patients with Diabetic Peripheral Neuropathic Pain..It will also learn about the safety of drug YJ001 Spray.This trial is divided into two parts. The first part of the trial is designed as a randomized, double-blind, double-dummy, parallel-controlled, multi-center clinical trial with positive reference product and placebo; the second part is designed as a single-arm, open-label, multi-center clinical trial.In the first part, the trial was divided into the test group, the positive control group, and the placebo group.\n\nIn the first part,The experimental group received YJ001 spray + clobazam besylate capsule placebo, the positive control group received YJ001 spray placebo + clobazam besylate capsule, and the placebo group received YJ001 spray placebo + clobazam besylate capsule placebo. In the second part, all participants were treated with the investigational product, and 30 trial participants underwent PK blood sample collection according to the protocol.\n\nPart I of the trial : To evaluate the efficacy and safety of YJ001 spray in treating diabetic peripheral neuropathic pain.\n\nPart 2 of the trial: Evaluate the long-term efficacy and the pharmacokinetic characteristics of YJ001 spray in treating dia betic peripheral neuropathic pain at the clinically recommended dosage.\n\nParticipants will:\n\nApply spray topically to both feet twice daily, with six sprays per foot at each administration.\n\nVisit the clinic once every 1 or 2 or 4 weeks for checkups and tests Complete a study diary daily to record pain intensity, sleep interference, study-drug administration, and spray-related respiratory irritation.",[167],"Diabetic Peripheral Neuropathic Pain (DPNP)","2026-09-29",{"date":170,"type":171},"2026-10-05","ACTUAL",{"date":173,"type":171},"2026-08-03",{"date":175,"type":161},"2028-08-30",{"name":5,"class":6},1]