[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-peripheral-neuropathic-pain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-peripheral-neuropathic-pain":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,63,84,107,130,153,179],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100564417","phase-3-evaluation-of-efficacy-and-safety-of-suzetrigine-for-pain-associated-with-diabetic-peripheral-neuropathy-100564417",false,"NCT06628908","Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy","A Phase 3, Randomized, Double-blind, Placebo- and Active-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy","Key Inclusion Criteria:\n\n* Body weight greater than or equal to (≥) 45 kilogram (kg)\n* Body mass index (BMI) ≥18.0 to less than (\\\u003C) 40.0 kilogram per meter square (kg\u002Fm\\^2)\n* Diagnosis of diabetes mellitus type 1 or type 2 by glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN\n* Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period\n\nKey Exclusion Criteria:\n\n* More than 3 missing daily NPRS scores during the 7-day Baseline Period\n* Any sensory abnormality (excluding DPN) as pre-specified in the protocol\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years","80 Years",{"count":20,"type":21},1100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).",[27],"Diabetic Peripheral Neuropathic Pain","RECRUITING","2026-06-12",{"date":31,"type":32},"2026-06-15","ACTUAL",{"date":34,"type":32},"2024-10-01",{"date":36,"type":21},"2027-05-31",{"name":38,"class":39},"Vertex Pharmaceuticals Incorporated","INDUSTRY",76,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100563722","phase-2-evaluation-of-efficacy-and-safety-of-vx-993-for-pain-associated-with-diabetic-peripheral-neuropathy-100563722","NCT06619860","Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy","A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of Oral VX-993 in Subjects With Pain Associated With Diabetic Peripheral Neuropathy","Key Inclusion Criteria:\n\n* Diagnosis of diabetes mellitus type 1 or type 2 with\n\n  * Glycosylated hemoglobin A1c (HbA1c) less than or equal to (≤) 9% and\n  * Presence of bilateral pain in lower extremities due to DPN (defined as a symmetric, length-dependent sensory or sensorimotor polyneuropathy) for at least 1 year\n\nKey Exclusion Criteria:\n\n* Painful neuropathy other than DPN\n* History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)\n* History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":49,"type":21},300,[51],"PHASE2","The purpose of this study is to evaluate the efficacy, safety, and tolerability of VX-993 in participants with pain associated with Diabetic Peripheral Neuropathy (DPN)",[27],"2026-05-29",{"date":56,"type":32},"2026-06-01",{"date":58,"type":32},"2024-10-18",{"date":60,"type":21},"2027-04-22",{"name":38,"class":39},47,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100610733","phase-3-evaluation-of-efficacy-and-safety-of-suzetrigine-suz-for-pain-associated-with-diabetic-peripheral-neuropathy-100610733","NCT07231419","Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy","A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy","Key Inclusion Criteria:\n\n* Body weight greater than or equal to (≥)45 kilogram (kg)\n* Body mass index (BMI) ≥18 to less than (\\\u003C) 40 kilogram per meter square (kg\u002Fm\\^2)\n* Diagnosis of diabetes mellitus type 1 or type 2 and with glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN for at least 1 year\n* Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period\n\nKey Exclusion Criteria:\n\n* More than 3 missing daily NPRS scores during the 7-day Baseline Period\n* Received Journavx within 30 days of study drug dosing\n* Any sensory abnormality (excluding DPN) as pre-specified in the protocol\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":71,"type":21},734,[24],"The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine in participants with pain associated with diabetic peripheral neuropathy (DPN).",[27],"2026-05-18",{"date":77,"type":32},"2026-05-19",{"date":79,"type":32},"2025-11-21",{"date":81,"type":21},"2027-04-06",{"name":38,"class":39},75,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100621984","phase-1-a-study-of-hrs-2129-in-patients-with-diabetic-peripheral-neuropathic-pain-100621984","NCT07377721","A Study of HRS-2129 in Patients With Diabetic Peripheral Neuropathic Pain","A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Pregabalin Capsule Controlled, Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Chinese Patients With Diabetic Peripheral Neuropathic Pain","Inclusion Criteria:\n\n1. Able and willing to provide a written informed consent.\n2. Males or females aged ≥18years of age inclusive.\n3. Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 3 months.\n4. HbA1c ≤ 9.0% at screening and on a stable antidiabetic medication regimen for at least 30 days prior to screening as far as possible.\n5. At Screening, pain scale (Visual Analog Scale, VAS) of ≥ 40 mm and \\\u003C 90 mm.\n\nExclusion Criteria:\n\n1. Subjects with a history of severe allergies.\n2. Peripheral neuropathy or pain unrelated to diabetic peripheral neuropathy (DPN) that may confuse the assessment of diabetic peripheral neuropathic pain (DPNP).\n3. Subjects with abnormal liver and renal function.\n4. Corrected QT Interval (QTc): \\> 450 ms (male), \\> 470 ms (female).\n5. Failure to response to previous treatment with pregabalin at doses ≥ 300 mg\u002Fd or gabapentin at doses ≥ 1200 mg\u002Fd for treatment of diabetic peripheral neuropathic pain (DPNP).\n6. History of suicidal behavior or attempted suicide.\n7. Participated in another clinical study within 3 months prior to screening.",{"count":92,"type":21},168,[94],"PHASE1","This study aims to investigate the efficacy and safety of HRS-2129 in Chinese diabetic peripheral neuropathic pain (DPNP) in comparison to placebo.",[27],"2026-04-14",{"date":99,"type":32},"2026-04-15",{"date":101,"type":32},"2026-03-24",{"date":103,"type":21},"2026-11",{"name":105,"class":39},"Shandong Suncadia Medicine Co., Ltd.",2,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100614855","phase-2-a-chronic-pain-master-protocol-cpmp-a-study-of-ly4065967-in-participants-with-diabetic-peripheral-neuropathic-pain-100614855","NCT07285018","A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain","Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Diabetic Peripheral Neuropathic Pain","NP07","Inclusion Criteria:\n\n* Have presence of diabetic peripheral neuropathy, of symmetrical nature and in lower extremities for ≥6 months and diagnosed by a score of Part B ≥3 on Michigan Neuropathy Screening Instrument (©University of Michigan)\n* Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.\n* Have an HbA1c \\\u003C11% and on a stable regimen for treatment of diabetes at least 90 days prior to screening\n* Have a body mass index at screening of ≤40 kilogram per meter squared (kg\u002Fm2)\n\nExclusion Criteria:\n\n* Are pregnant or breastfeeding\n* Have a history of other potentially causative and\u002For confounding sources of pain that may impair self-assessment of pain due to diabetic peripheral neuropathic pain (DPNP)\n* Have lower limb amputation due to diabetes inclusive of great toe (metatarsal bone)\n* Have serum vitamin B12 ≤200 picogram per milliliter (pg\u002FmL)\n* Have an abnormal BP (systolic BP \\>140 mm Hg and diastolic BP\\>90 mm Hg) at screening\n* Have history or current clinically significant cardiac disease, including arrhythmia, aortic aneurysm, heart failure, current electrolyte abnormalities, or any other conditions that could predispose to arrhythmia in the judgement of the investigator",{"count":116,"type":21},150,[51],"The purpose of this study is to test the safety and efficacy of study drug LY4065967 for the treatment of diabetic peripheral neuropathic pain (DPNP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.",[27],"2026-03-26",{"date":122,"type":32},"2026-03-27",{"date":124,"type":32},"2026-02-16",{"date":126,"type":21},"2027-07",{"name":128,"class":39},"Eli Lilly and Company",37,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":4},"100605186","phase-2-evaluate-the-efficacy-and-safety-of-hl-1186-in-patients-with-diabetic-peripheral-neuropathic-pain-100605186","NCT07159243","Evaluate the Efficacy and Safety of HL-1186 in Patients With Diabetic Peripheral Neuropathic Pain","A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel-designed Clinical Study to Evaluate the Efficacy and Safety of HL-1186 in Patients With Diabetic Peripheral Neuropathic Pain","Inclusion Criteria:\n\n1. Aged between 18 and 75 years old (inclusive), regardless of gender.\n2. With Type 1 or Type 2 diabetes mellitus, with a diagnosis of DPNP for at least 6 months.\n3. Screening period: ADPS ranging from 4 to 9 points, and Visual Analog Scale (VAS) scores of 40mm - 90mm in two different days.\n4. The hypoglycemic regimen has been stable for at least 4 weeks before enrollment, and the glycated hemoglobin (HbA1c) during the screening period is ≤ 9%.\n5. Participants fully understand the purpose, characteristics, methods of the trial and possible adverse events, voluntarily participate in the trial and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Participants with any pain other than DPNP, or with other diseases that the investigator deems may affect the evaluation of DPNP.\n2. Participants who are allergic to the active ingredients or excipients of HL-1186, HL-1186 placebo, or paracetamol tablets, or who have an allergic constitution, or have a history of allergies to ≥ 3 substances.\n3. Participants who have used drugs that may damage nerves (such as tumor chemotherapy drugs) after being diagnosed with DPNP.\n4. Participants who used any prohibited drugs within 2 weeks before screening (or within 5 half-lives after the last use of such prohibited drugs at the time of screening, whichever is longer).\n5. Participants who had acute diabetic complications within 6 months before screening, such as diabetic ketoacidosis, hyperglycemic hyperosmolar state, lactic acidosis, acute severe hypoglycemia, etc., or had lower limb amputation (except toe amputation) at the time of screening.\n6. Participants with clinically significant abnormalities in the 12-lead electrocardiogram (ECG) during the screening period (such as QTcF ≥ 450ms), or with severe cardiopulmonary diseases that the investigator deems inappropriate for inclusion, such as unstable angina pectoris, myocardial infarction, severe arrhythmias requiring treatment (such as grade Ⅲ atrioventricular block), NYHA cardiac function class ≥ Ⅲ, poorly controlled hypertension (systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg), recurrent asthma, etc.\n7. Participants with neuropsychiatric system diseases that the investigator deems may affect the participant's evaluation of DPNP or scale evaluation, such as depression, anxiety, epilepsy, recurrent dizziness, memory and cognitive impairment, a history of suicide attempts or suicidal tendencies, etc.\n8. Participants with a history of malignant tumors within 2 years before screening (except for participants with basal cell carcinoma, squamous cell carcinoma, and stage 0 cervical carcinoma in situ that have been confirmed cured by the investigator).\n9. Participants with clinically significant and unstable diseases of the nervous system, mental system, ophthalmology, hepatobiliary system, respiratory system, hematological system, or cardiovascular system within 1 year before screening, and the investigator assesses that such diseases may endanger the participant's safety during the trial, restrict the participant from completing the study procedures, or affect the research purpose.\n10. Participants with positive human immunodeficiency virus antibody, positive syphilis serological test, positive hepatitis B virus surface antigen with hepatitis B virus DNA \\> ULN, or positive hepatitis C virus antibody with hepatitis C virus RNA \\> ULN.\n11. Participants with a history of alcoholism or drug abuse within 2 years before screening.\n12. Female participants who are pregnant, breastfeeding (within 1 year after delivery), or with a positive pregnancy test.\n13. Participants of childbearing potential who have plans to conceive, freeze or donate sperm\u002Feggs from the time of signing the informed consent form until 6 months after the last dose, or who refuse to adopt effective contraceptive measures (complete abstinence, barrier methods, contraceptives, intrauterine devices, or having undergone sterilization surgery).\n14. Participants who have participated in other drug or medical device trials within 3 months before screening or are currently participating in other clinical trials.\n15. Participants deemed by the investigator to be unsuitable for participating in this study for any reason.","75 Years",{"count":139,"type":21},180,[51],"This is a multi-center, randomized, double-blind, placebo-controlled study design evaluating the safety, efficacy, and PK parameter of HL-1186 tablet for diabetic peripheral neuropathic pain.",[27],"NOT_YET_RECRUITING","2025-09-03",{"date":146,"type":32},"2025-09-08",{"date":148,"type":21},"2025-09",{"date":150,"type":21},"2026-10",{"name":152,"class":39},"Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":163,"conditions":164,"keywords":165,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100543841","phase-1-mad-study-to-assess-the-safety-tolerability-pks-and-efficacy-of-yj001-for-spray-use-in-patients-with-dpnp-100543841","NCT06361108","MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients With DPNP","A Phase I, Randomized, Double-Blind, Placebo Controlled MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of Topical Application of YJ001 for Spray Use in Patients With DPNP","Inclusion Criteria:\n\n* Male or female, between the ages of 18 to 80 years at screening, both inclusive.\n* Subjects voluntarily consenting for participation in the study and having signed informed consent document. Subjects are required to understand verbal and\u002For written English or any other language in which a certified translation of the informed consent is available.\n* Body mass index (BMI) between 19 to 42 kg\u002Fm2 (both inclusive) at screening, calculated as weight (kg)\u002Fheight2 (m2). Subjects must have two feet. Each foot must have five digits. Each foot must have at least total surface area of 450 cm2 measured from below the ankle to the toes including both dorsum and plantar areas.\n* The subject is diagnosed with Type 1 or Type 2 diabetes, and has a history of DPNP for at least 3 months based on participant report or medical history.\n* The subject should have a glycemic control that has been optimized and has been stable for at least 3 months prior to randomization. The subject has used a stable regimen of antidiabetic agents (oral) and\u002For insulin for at least 3 months before screening.\n* Glycated hemoglobin (HbA1c) ≤ 10% at screening.\n* Participants who have a weekly mean score of at least 4 based upon the daily mean scores using 11-point Numeric Rating Scale (NRS) in the daily diary (rated twice daily, once in the morning and the other in the evening) from Day -7 through Day 1 (should be calculated from records 7 days immediately prior to study drug administration).\n* Males must not donate sperm until 90 days after last dose of study drug and must be willing to use a condom during heterosexual activity for up to 90 days after the application of the study drug.\n* Females must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation \\[including clip, cauterization methods and coil\\], bilateral oophorectomy or hysterectomy, and needs to be confirmed follicle-stimulating hormone \\[FSH\\] level \\>40 IU\u002FL), or of childbearing potential either practicing true abstinence or practicing 2 effective means of contraception for at least 4 weeks prior to randomization, and until 28 days after study drug administration:\n\n  1. Intrauterine device (IUD) or IUD hormone-releasing system.\n  2. Combined estrogen and progestogen containing hormonal contraception (oral, intravaginal, or transdermal) associated with inhibition of ovulation.\n  3. Progesterone-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation.\n  4. Intrauterine hormone-releasing system.\n  5. Double-barrier method (condoms, contraceptive sponge, diaphragm, or vaginal ring with spermicide).\n* Able and willing to comply with all study requirements.\n\nExclusion Criteria:\n\n* Current participation in another investigational drug or device study or treated with an investigational drug within 30 days or 5 half-lives, whichever is longer, before dosing.\n* History of clinically significant drug, food allergy, skin allergy, or sensitivity to drugs of the same class (e.g., 5-aminosalicylic acid, sulfasalazine, and salicylates) or known hypersensitivity to YJ001 or any of its components.\n* History of asthma. Adults with history of benign (resolved) childhood asthma may be included.\n* Any subject who suffers severe peripheral vascular disease (e.g., intermittent claudication) at screening, and is not suitable to be involved in the study as per investigator evaluation.\n* Any subject who suffers severe cardiovascular and cerebrovascular disease (e.g., severe arrhythmia, heart failure, myocardial infarction, unstable angina pectoris, atherosclerosis, stroke, sequela of stroke, etc.), severe gastrointestinal tract disease or other serious disease (e.g., cancer) which, in the opinion of the Investigator, would prevent the subject from fully participating in the study.\n* Any subject who suffers chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) or multifocal motor neuropathy (MMN).\n* Any subject who has a history of moderate to severe depression, obvious neurological or mental disorder not related to neuropathic pain but may interfere with rating of pain, as well as poly neuropathy, numbness, feeling of pins and needles and weakness in extremities, other serious pain cannot be clearly differentiated from or conditions that may interfere with rating of neuropathic pain. Subjects with weakness but w\u002Fo sensory complaints may be included.\n* Any other medical, psychological, or social condition which, in the opinion of the Investigator, would prevent the subject from fully participating in the study, would represent a concern for study compliance, or would constitute a safety concern to the subject.\n* Any subject who has suffered one or more severe hypoglycemia event (defined as neurofunctional hypoglycemia that needs third-party assistance) within 6 months prior to screening.\n* Pain scores \\\u003C 3 on the NRS over twice during the one-week run-in period.\n* Any subject with unstable or poorly controlled abnormality in blood pressure or lipid (blood pressure ≥ 160 mmHg\u002F95 mmHg, total cholesterol ≥ 6.2 mmol\u002FL, and\u002For triglyceride ≥ 6.3 mmol\u002FL) at screening.\n* Any subject with abnormal renal function, estimated glomerular filtration rate (eGFR)\\\u003C60 mL\u002Fmin\u002F1.73 m2.\n\neGFR=186×Scr\\^-1.154×Age\\^-0.203×(0.742 for Female)\n\n* Any subject with abnormal liver function, liver enzymes (alanine aminotransferase \\[ALT\\] and aspartate aminotransferase \\[AST\\]) greater than 2 times upper limit of normal.\n* Consumed 8 units or more of alcoholic beverages per week for women or 15 units or more of alcoholic beverages per week for men at any time in the 6 months before dosing (1 unit of ethanol is equivalent to 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of spirits) or history of drug or alcohol abuse within the 6 months before dosing or evidence of such abuse as indicated by inquiry, medical history or the laboratory assays conducted during screening. Any subject who has past history of heavy drinking or alcoholism.\n* Any subject who consumes more than 5 cigarettes per day within 30 days before study drug dosing or who cannot stop using any tobacco- or nicotine-containing product during the duration of the trial.\n* Positive screening or check-in alcohol\u002Fdrugs of abuse\u002Fcotinine screen.\n* Positive test results for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening. SARS-CoV-2 testing will be either antigen, nasopharyngeal (NP) or nasal swab polymerase chain reaction (PCR) performed at Day -1, and in accordance with Centers for Disease Control and Prevention (CDC), FDA and local health authorities at the time of enrollment for this study. Participants not willing to comply with the investigational site's Coronavirus Disease 2019 (COVID 19) policy.\n* Female volunteers who are pregnant or lactating.\n* Have a significant acute illness within 7 days prior to study drug administration or have had a major illness or hospitalization within 1 month prior to study drug administration.\n* Systemic or topical use of aspirin or salicylic acid containing products or sulfasalazine\u002Fsalicylic acid derivatives within 14 days of study drug dosing.\n* Use of other prescription and non-prescription medications (with the exception of permitted concomitant medications, oral contraceptives, combined estrogen and progestogen containing hormonal contraception and progestogen-only hormonal contraception), such as blood thinners, or sucralfate or herbal preparations within 14 days or 5 half-lives (whichever is longer) before study drug dosing, or use of an over-the-counter medication, vitamins, or supplements (including fish liver oils) within 14 days before study drug dosing.\n* Positive screen on Hepatitis B, Hepatitis C, or Human immunodeficiency virus (HIV) at the time of screening evaluations.\n* History of blood donation of more than 500 mL in the last 2 months prior to screening.\n* History or evidence of poor venous access.\n* History of bleeding disorders.\n* Any subject with foot ulcers and\u002For pedal oedema. Presence of skin disorders, tattoos, skin breakdown, or other skin conditions on either foot that may interfere with the objectives of the study (as per investigator evaluation).\n* Use of any kind of topical lotions, sunscreen, heating pads\u002Fcooling pads on feet for at least 24 hours before study drug is administered and until End-of-Study.\n* An employee of the study center or Sponsor or family member of a study center employee\n* Unwilling to stay in the clinical unit for the required duration as per the protocol or consume the standard meal to be provided as per the protocol.\n* Any subject considering or scheduled to undergo any surgical procedure from screening to at least 7 days post dose.",{"count":161,"type":21},24,[94],"This Phase I, randomized, double-blind and placebo controlled study is to evaluate the safety, tolerability, and PK, and to preliminarily assess the efficacy of topically administered YJ001 in a multiple-ascending dose (MAD) fashion in the patients with DPNP. The study will be conducted at a single study center.\n\nIn this study, 2 cohorts (N=24, 12 subjects for each cohort), each cohort will consist of 10 active and 2 placebo, with approximately equal numbers of male and female subjects.\n\nEach subject will be administered a single dose of YJ001 as multiple sprays topically on both feet and below the ankle in the morning on Day 1 and Day 2, and will be administered as twice daily doses once in the morning and the other in the evening (with an interval of 11 to 13 h) from Day 3 through Day 11.",[27],[166,167,168],"Diabetes","Diabetic Peripheral Neuropathic(DPN)","Diabetic Peripheral Neuropathic Pain(DPNP)","2025-08-11",{"date":171,"type":32},"2025-08-13",{"date":173,"type":32},"2024-05-16",{"date":175,"type":21},"2026-06-30",{"name":177,"class":39},"Zhejiang Hanmai Pharmaceutical Technology Co., Ltd.",1,{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":137,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":178},"100553776","phase-2-efficacy-and-safety-of-hsk16149-capsule-in-chinese-patients-with-diabetic-peripheral-neuropathic-pain-who-had-an-inadequate-response-to-pregabalin-100553776","NCT06490484","Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain Who Had an Inadequate Response to Pregabalin","Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain Who Had an Inadequate Response to Pregabalin: A Prospective, Multicenter, Randomized, Double-Blind, Double-Dummy, Pregabalin-controlled Phase 2 Study","Inclusion Criteria:\n\n1. Signed informed consent;\n2. Males or females aged 18-75 years of age inclusive;\n3. Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 6 months;\n4. HbA1c ≤ 11.0% at screening and on a stable anti-diabetic medication regimen for at least 30 days prior to screening;\n5. Have a visual analog scale (VAS) pain value ≥60 mm in the past 24 h during screening;\n6. DPNP patients are currently receiving continuous treatment with pregabalin for more than 4 weeks who had an inadequate response.\n\nExclusion Criteria:\n\n1. Peripheral neuropathy or pain unrelated to DPN that may confuse the assessment of DPNP.\n2. Skin conditions in the area affected by neurupathy that could alter sensation.\n3. Chronic systemic diseases that may affect subjects' participation in the study.\n4. Severe hematologic, hepatic or renal dysfunction, the subject will be excluded if:\n\n   1. Neutrophils \\\u003C 1.5 × 10\\^9\u002FL, or platelet \\\u003C 90 × 10\\^9\u002FL, or hemoglobin \\\u003C 100 g\u002FL;\n   2. AST\u002FALT \\> 2.5 × upper limit of normal (ULN), or TBIL \\> 1.5 × ULN;\n   3. Estimation of glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin \u002F 1.73 m\\^2;\n   4. Creatine kinase \\> 2.0 × ULN.\n5. History of substance abuse or alcohol abuse.\n6. Acute complications of diabetes in the 6 months prior to screening.\n7. Any active infections at screening.\n8. HBsAg or HCV Ab positive, or HIV Ab positive, or serum TP Ab positive.\n9. Inability or unwillingness to discontinue any other prohibited concomitant medications.\n10. History of allergic or medically significant adverse reaction to investigational products or their excipients, duloxetine or related compounds.\n11. History of suicidal behavior or attempted suicide.\n12. Pregnant or preparing for pregnancy or breastfeeding during the study period, or subjects were not willing to use reliable contraceptives methods from the date of ICF signature until 28 days after the last trial drug administration, or planning to use progesterone contraceptives during this period.\n13. Participated in another clinical study within 30 days prior to screening.\n14. Other conditions of the subjects who are unlikely to comply with the protocol.\n15. The investigators determine that there are other conditions that are not suitable for participation in this study.",{"count":187,"type":21},90,[51],"Investigate the efficacy and safety of HSK16149 capsule in Chinese patients with Diabetic Peripheral Neuropathic Pain (DPNP) who had an inadequate response to Pregabalin, following 4 weeks treatment in comparison to Pregabalin",[27],"2024-06-28",{"date":193,"type":32},"2024-07-08",{"date":195,"type":32},"2024-04-19",{"date":197,"type":21},"2024-07-14",{"name":199,"class":39},"Haisco Pharmaceutical Group Co., Ltd."]