[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100336932":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":10,"locations":16,"responsibleParty":62,"collaborators":10,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":10,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":10,"enrollmentInfo":73,"targetDuration":10,"studyType":76,"phases":10,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":83,"whyStopped":10,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Takeda","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Neosaldina",null,"Participants with episodic TTH and who have already been treated with Neosaldina will be included in the observation period of this study. During the observation period, participants will be administered with Neosaldina 2 tablets, orally in the beginning of the TTH episode, every 6 hours, and at maximum of 8 tablets per day, according to regular clinical practice of the physicians. The participants will be observed in this study from Day 1 until Day 45.",[13],{"name":14,"affiliation":5,"role":15},"Medical Director","STUDY_DIRECTOR",[17,30,39,48,56],{"facility":18,"status":10,"city":19,"state":20,"zip":21,"country":22,"countryCode":23,"cosmosGeoPoint":24,"geoPoint":29,"contacts":10},"Fundacao do ABC","Santo André","São Paulo","09060-870","Brazil","BR",{"type":25,"coordinates":26},"Point",[27,28],-46.53833,-23.66389,{"lat":28,"lon":27},{"facility":31,"status":10,"city":32,"state":20,"zip":33,"country":22,"countryCode":23,"cosmosGeoPoint":34,"geoPoint":38,"contacts":10},"Universidade Metropolitana de Santos","Santos","11035-050",{"type":25,"coordinates":35},[36,37],-46.33361,-23.96083,{"lat":37,"lon":36},{"facility":40,"status":10,"city":41,"state":20,"zip":42,"country":22,"countryCode":23,"cosmosGeoPoint":43,"geoPoint":47,"contacts":10},"Cemec Centro Multidisciplinar de Estudos Clinicos Ltda-Epp","São Bernardo do Campo","09715-090",{"type":25,"coordinates":44},[45,46],-46.565,-23.69389,{"lat":46,"lon":45},{"facility":49,"status":10,"city":20,"state":20,"zip":50,"country":22,"countryCode":23,"cosmosGeoPoint":51,"geoPoint":55,"contacts":10},"Sociedade Brasileira e Japonesa de Beneficencia Santa Cruz","04122-000",{"type":25,"coordinates":52},[53,54],-46.63611,-23.5475,{"lat":54,"lon":53},{"facility":57,"status":10,"city":20,"state":20,"zip":58,"country":22,"countryCode":23,"cosmosGeoPoint":59,"geoPoint":61,"contacts":10},"Cepic- Centro Paulista de Investigacao Clinica E Servicos Medicos Ltda","04266-010",{"type":25,"coordinates":60},[53,54],{"lat":54,"lon":53},{"type":63,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100336932","a-study-to-describe-pain-intensity-pain-relief-and-safety-of-neosaldina-in-the-treatment-of-tension-type-headaches-tth-in-healthy-participants-100336932",true,"NCT03666858","A Study to Describe Pain Intensity, Pain Relief and Safety of Neosaldina in the Treatment of Tension-type Headaches (TTH) in Healthy Participants","An Observational, Single-Arm Study to Describe Pain Intensity, Pain Relief and Safety of Neosaldina in the Treatment of Tension-Type Headaches in Healthy Subjects","Inclusion Criteria:\n\n1. Confirmed diagnosis of episodic TTH, as determined by the International Classification of Headache Disorders.\n2. Healthy participants who was prescribed 2 tablets of Neosaldina for episodic TTH.\n3. Receive treatment according to the Summary of Product Characteristics for Neosaldina.\n4. Has access to a mobile phone with the ability to download the app with the study questionnaire.\n5. Has at least 1 episode of TTH per month.\n\nExclusion Criteria:\n\n1. Currently participates or plans to participate in an interventional clinical trial.\n2. Has hypersensitivity or intolerance to dypirone (or pyrazolonic derivatives) or other components of the product formula.\n3. Has history of migraine, cluster headaches, chronic TTH or any other type of primary headache other than episodic TTH.\n4. Has suspected secondary headache.\n5. Has serious comorbidities (hypertension, blood dyscrasias, malignant neoplasms, any type of hepatitis or kidney disease, disorders of the hematopoietic system, insufficient function of the bone marrow or certain metabolic diseases, such as hepatic porphyria or congenital deficiency of glucose-6-phosphate dehydrogenase) or taking any medications which might confound the pharmacological effects of the study drug (example immunosuppressive drugs, and beta blockers, anticonvulsivants, antidepressants) within 30 days before the start of study.\n6. Women who may be pregnant or breastfeeding during the course of the study.\n7. Has history of alcohol abuse or other drugs according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5).\n8. Has mental incapacity, unwillingness or language barriers unable to understand the guidelines specified in this protocol.\n9. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.","ALL","18 Years",{"count":74,"type":75},216,"ACTUAL","OBSERVATIONAL","The purpose of this study is to describe pain relief in TTH with Neosaldina treatment.",[79,80],"Healthy Volunteers","Tension-type Headache",[82],"Drug Therapy","COMPLETED","2021-05-07",{"date":86,"type":75},"2021-06-02",{"date":88,"type":75},"2018-12-20",{"date":90,"type":75},"2019-08-19",{"name":5,"class":6},5]