[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Insud Pharma\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":81},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"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":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100590520","phase-2-sublingual-oxytocin-for-the-prevention-of-post-partum-hemorrhage-100590520",false,"NCT06968481","Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage","Phase 2, Open-label, Randomized, Dose Ascending Trial to Evaluate the Efficacy and Safety of Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage Caused by Uterine Atony in Term Pregnant Women With Uncomplicated Vaginal Delivery","Inclusion Criteria:\n\n1. Women willing and able to provide Informed consent.\n2. Women who are able to understand, confirm and give informed consent during an antenatal visit or first stage of labor (cervical dilation \\\u003C6 cm).\n3. Healthy, primiparous or multiparous (2-4 deliveries), term-pregnant female with a gestational age of 37 to 42 weeks (inclusive). Gestational age should be confirmed with an obstetrical ultrasound if available.\n4. Aged between 18 and 40 years (both inclusive).\n5. Confirmed singleton pregnancy.\n6. Based on the Investigator assessment, maternal and fetal conditions are met to expect a vaginal delivery.\n7. For participants in the PK subgroup: women with baseline hemoglobin level ≥11 g\u002FdL.\n\nExclusion Criteria:\n\n1. Women who are unable to provide written Informed consent.\n2. Women undergoing an elective or emergency cesarean section.\n3. Conditions predisposing to uterine atony and PPH (e.g., previous PPH, placenta praevia, multiple gestation, severe pre-eclampsia, polyhydramnios, uterine fibroids, need for induction of labor, bleeding diathesis, sepsis, body mass index \\[BMI\\] ˃ 30 kg\u002Fm2 , macrosomia with estimated fetal weight \\>4500 g, if antenatal ultrasound was performed).\n4. Women with moderate or severe anemia (defined as Hb \\\u003C10 g\u002FdL).\n5. Women who have undergone female genital mutilation.\n6. Known allergies to carbetocin, other oxytocin homologues or excipients in the medicinal products used in the trial.\n7. Oral conditions before administration of sublingual oxytocin such as moderate erythema and edema, severe irritation\u002Finflammation, moderate or severe abrasion.\n8. Conditions predisposing to myocardial ischemia due to pre-existing cardiovascular diseases (such as hypertrophic cardiomyopathy, valvular heart disease and\u002For ischemic heart disease, including vasospasm of the coronary arteries) or known long QT syndrome or related symptoms.\n9. Any clinically significant abnormality following review of medical history, laboratory result and physical examination at screening as judged by the Investigator (e.g., severe anemia, antepartum hemorrhage, mental disorder, history of cervical cancer or history of severe infection of the uterus, religious beliefs prohibiting blood transfusions).\n10. Previous surgery of the cervix or uterus or any other preexisting condition that could interfere with the measurement of uterine contractility.\n11. Current use or use within 30 days before the start of the IMP or reference product of one or more of predefined medications","FEMALE","18 Years","40 Years",{"count":20,"type":21},330,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","An open-label, randomized, single-center, dose ascending trial will be conducted to evaluate the efficacy and safety of sublingual oxytocin for the prevention of post-partum hemorrhage caused by uterine atony in term pregnant women having an uncomplicated vaginal delivery.",[27],"Post Partum Hemorrhage",[29,30,31,32,33,34,35],"sublingual oxytocin","oxytocin","post-partum hemorrhage","severe post-partum hemorrhage","SPPH","Prevention of post-partum hemorrhage","Efficacy and safety","NOT_YET_RECRUITING","2026-04-20",{"date":39,"type":40},"2026-04-23","ACTUAL",{"date":42,"type":21},"2026-05-30",{"date":44,"type":21},"2026-10-30",{"name":46,"class":47},"Insud Pharma","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":5},"100537783","phase-3-real-world-evaluation-of-an-albendazole-ivermectin-coformulation-safety-and-effectiveness-100537783","NCT06282315","Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness","A Pragmatic Phase III Multicentre Clinical Trial to Evaluate the Safety and Effectiveness of a Single Dose of an Albendazole-Ivermectin Coformulation vs Albendazole for Preventive Chemotherapy of Soil-Transmitted Helminth Infections in School-Aged Children","Inclusion Criteria:\n\nIndividuals of both sexes that attend the selected schools in the trial areas in Ghana and Kenya that meet the following criteria:\n\n1. Age: 5 to 17 years old (included).\n2. Height: over 110 cm.\n3. Parental acceptance to participate in the study by obtaining written informed consent approved by the Ethics Committee. Written assent will also be obtained from children according to the local national legislation (12-17 years old).\n\n   Exclusion Criteria:\n4. Epidemiological risk of being infected by Loa loa, defined as those who have visited any of the following countries: Angola, Cameroon, Central Africa Republic, Chad, Congo, Democratic Republic of the Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan.\n5. Serious medical illness, defined as participants showing symptoms of acute illness which could hamper the participation in the trial, such as high-grade fever, severe diarrhoea, neurological symptoms or others, per investigator's criteria.\n6. Any condition prevents the appropriate evaluation and follow-up of the participant, per the investigator's criteria.\n7. Known hypersensitivity to any component of either study treatment.\n8. Pregnant or first week post-partum: female participants who are post-menarche must have a negative urine pregnancy test at screening.",true,"ALL","5 Years","17 Years",{"count":61,"type":21},20000,[63],"PHASE3","An open-label, randomized by school, two-arm pragmatic trial, will be conducted involving two study sites in Sub-Saharan-Africa (SSA), Ghana and Kenya, to evaluate safety and effectiveness of the newly developed fixed dose combination (FDC) of albendazole (ALB) and ivermectin (IVM) as a single dose to treat Soil-Transmitted Helminths (STH), compared to the standard dose ALB single dose for the treatment and control of STH (REALISE study: Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness). The general objectives are to validate the benefits of FDC through this pragmatic trial in a context of mass drug administration (MDA) programme to evaluate the safety as a primary endpoint and effectiveness profile as a secondary endpoint, in a large population of school-aged children.",[66],"Soil-Transmitted Helminths",[68,69,70,71],"STH","albendazole","ivermectin","hookworms","RECRUITING","2025-09-08",{"date":75,"type":40},"2025-09-15",{"date":77,"type":40},"2025-09-01",{"date":79,"type":21},"2027-02",{"name":46,"class":47},""]