[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100413678":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":29,"centralContacts":51,"locations":57,"responsibleParty":72,"collaborators":29,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":29,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":29,"enrollmentInfo":83,"targetDuration":29,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":29,"overallStatus":60,"whyStopped":29,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"EMS","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Praga formulation","EXPERIMENTAL","The study is double-dummy. The participant must take pills twice a day, as follows:\n\nMorning:Placebo pregabalin tablet, oral Night: Placebo pregabalin tablet, oral plus Praga formulation,oral",[13,14,15],"Drug: Praga formulation","Other: Placebo pregabalin 75mg","Other: Placebo Pregabalin 150mg",{"label":17,"type":18,"description":19,"interventionNames":20},"Pregabalin","ACTIVE_COMPARATOR","The study is double-dummy. The participant must take pills twice a day, as follows:\n\nMorning:Pregabalin tablet, oral Night: Pregabalin tablet plus, oral placebo Praga formulation, oral",[21,22,23],"Drug: Pregabalin 75mg","Drug: Pregabalin 150mg","Other: Placebo Praga formulation",[25,30,35,39,43,47],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Praga formulation tablet",[9],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":29},"OTHER","Placebo pregabalin 75mg","Placebo pregabalin 75mg tablet",[9],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":29},"Placebo Pregabalin 150mg","Placebo Pregabalin 150mg tablet",[9],{"type":26,"name":40,"description":41,"armGroupLabels":42,"otherNames":29},"Pregabalin 75mg","Pregabalin 75mg tablet",[17],{"type":26,"name":44,"description":45,"armGroupLabels":46,"otherNames":29},"Pregabalin 150mg","Pregabalin 150mg tablet",[17],{"type":31,"name":48,"description":49,"armGroupLabels":50,"otherNames":29},"Placebo Praga formulation","Placebo Praga formulation tablet",[17],[52],{"name":53,"role":54,"phone":55,"phoneExt":29,"email":56},"Monalisa FB Oliveira, MD","CONTACT","+551938879851","pesquisa.clinica@ncfarma.com.br",[58],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":29},"Allegisa","RECRUITING","Campinas","São Paulo","13.084-791","Brazil","BR",{"type":67,"coordinates":68},"Point",[69,70],-47.06083,-22.90556,{"lat":70,"lon":69},{"type":73,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100413678","phase-3-efficacy-and-safety-of-praga-formulation-in-the-treatment-of-neuropathic-pain-100413678",false,"NCT04666714","Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain","National, Multicentre, Randomized, Double-blind, Double-dummy Phase III Clinical Trial to Evaluate the Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain","Inclusion Criteria:\n\n* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;\n* Participants of 18 years and older;\n* Diagnosis of type 2 or type 1 diabetes for at least 1 year;\n* No change in antidiabetic medication winthin 3 months;\n* Diagnosis of painful sensorimotor diabetic polyneuropathy;\n* Presence of at least one of the following symptoms: i. numbness in the toes, feet and \u002F or legs; ii. paresthesias (tingling and \u002F or neuropathic pain) in the toes, feet and \u002F or legs.\n* Presence of at least one of the following signs: i. symmetrical hypoesthesia of tactile, thermal or painful sensation (s) in the distal region of the legs; ii. hypoactive or abolished achilles reflexes;\n* Glycated hemoglobin ≤ 11%;\n* Score ≥ 12 points on the LANSS pain scale (Leeds Assessment of Neuropathic Symptoms and Signs); j) Participants with moderate to severe pain, a score ≥ 4 on the numerical pain scale (0-10 points);\n* Participants with moderate to severe neuropathic pain who recorded in the diary a minimum of 4 of the 7 days from the period to assess the baseline pain score.\n\nExclusion Criteria:\n\n* Known hypersensitivity to the formula components used during the clinical trial;\n* History of alcohol and\u002For substance abuse within 2 years;\n* Pregnant women, breastfeeding or planning to become pregnant, or women with the potential to become pregnant who are not using a reliable method of contraception;\n* History of pernicious anemia, uncontrolled hypothyroidism, chronic hepatitis B;\n* HIV diagnosis;\n* History of neurological disorder unrelated to diabetic neuropathy;\n* Non-responders to previous pregabalin treatment;\n* High variability in the baseline pain score;\n* Other conditions that may alter the sensitivity in the affected dermatome or in the area involved in neuropathic pain that may confuse pain assessment;\n* Severe psychiatric condition;\n* Cognitive decline that affect the participant from correctly answering the scales and questionnaires;\n* Clinically relevant cardiac abnormalities, which at the researcher's discretion represent a risk to participation in the trial;\n* Participant who has amputated lower limb due to complications from diabetes;\n* Renal failure, defined by the estimated glomerular filtration rate \\[eGFR\\] \\\u003C60 mL \u002F min \u002F 1.73 m2.","ALL","18 Years",{"count":84,"type":85},136,"ESTIMATED","INTERVENTIONAL",[88],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of Praga formulation in the treatment of neuropathic pain.",[91],"Neuropathic Pain","2025-03-12",{"date":94,"type":95},"2025-03-14","ACTUAL",{"date":97,"type":95},"2023-05-15",{"date":99,"type":85},"2025-12-31",{"name":5,"class":6},1]