[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100413678":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":28,"interventions":45,"overallOfficials":18,"centralContacts":71,"locations":77,"responsibleParty":92,"collaborators":18,"id":94,"slug":18,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":18,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":18,"enrollmentInfo":102,"targetDuration":18,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":18,"overallStatus":80,"whyStopped":18,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"EMS","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in pain intensity.","The change in pain intensity from baseline after 3 months of treatment will be scored by Numerical Rating Scale from 0 to 10 points, with 0 = no pain and 10 = worst possible pain, recorded in a participant diary.","3 months",[14],{"measure":15,"description":16,"timeFrame":17},"Incidence and severity of adverse events recorded during the study.","The incidence and severity of adverse events recorded during the study will be determined over 6 months.","6 months",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":25},"DOUBLE",[26,27],"PARTICIPANT","INVESTIGATOR",[29,37],{"label":30,"type":31,"description":32,"interventionNames":33},"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",[34,35,36],"Drug: Praga formulation","Other: Placebo pregabalin 75mg","Other: Placebo Pregabalin 150mg",{"label":38,"type":39,"description":40,"interventionNames":41},"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",[42,43,44],"Drug: Pregabalin 75mg","Drug: Pregabalin 150mg","Other: Placebo Praga formulation",[46,50,55,59,63,67],{"type":47,"name":30,"description":48,"armGroupLabels":49,"otherNames":18},"DRUG","Praga formulation tablet",[30],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":18},"OTHER","Placebo pregabalin 75mg","Placebo pregabalin 75mg tablet",[30],{"type":51,"name":56,"description":57,"armGroupLabels":58,"otherNames":18},"Placebo Pregabalin 150mg","Placebo Pregabalin 150mg tablet",[30],{"type":47,"name":60,"description":61,"armGroupLabels":62,"otherNames":18},"Pregabalin 75mg","Pregabalin 75mg tablet",[38],{"type":47,"name":64,"description":65,"armGroupLabels":66,"otherNames":18},"Pregabalin 150mg","Pregabalin 150mg tablet",[38],{"type":51,"name":68,"description":69,"armGroupLabels":70,"otherNames":18},"Placebo Praga formulation","Placebo Praga formulation tablet",[38],[72],{"name":73,"role":74,"phone":75,"phoneExt":18,"email":76},"Monalisa FB Oliveira, MD","CONTACT","+551938879851","pesquisa.clinica@ncfarma.com.br",[78],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":18},"Allegisa","RECRUITING","Campinas","São Paulo","13.084-791","Brazil","BR",{"type":87,"coordinates":88},"Point",[89,90],-47.06083,-22.90556,{"lat":90,"lon":89},{"type":93,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","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":103,"type":104},136,"ESTIMATED","INTERVENTIONAL",[107],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of Praga formulation in the treatment of neuropathic pain.",[110],"Neuropathic Pain","2025-03-12",{"date":113,"type":114},"2025-03-14","ACTUAL",{"date":116,"type":114},"2023-05-15",{"date":118,"type":104},"2025-12-31",{"name":5,"class":6},1]