[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484459":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":185,"collaborators":39,"id":187,"slug":188,"hasResults":189,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":39,"eligibilityCriteria":193,"healthyVolunteers":189,"sex":194,"minAge":195,"maxAge":196,"enrollmentInfo":197,"targetDuration":39,"studyType":200,"phases":201,"briefSummary":204,"conditions":205,"keywords":39,"overallStatus":56,"whyStopped":39,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},{"fullName":5,"class":6},"Shionogi Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: ≥ 12 to \u003C 18 Years","EXPERIMENTAL","Participants will receive 0.05 milligrams (mg) to 0.2 mg naldemedine based on their body weight once daily for 7 days.",[13],"Drug: Naldemedine",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2: ≥ 6 to \u003C 12 Years","Participants will receive 0.05 mg to 0.2 mg naldemedine based on their body weight once daily for 7 days.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3: ≥ 2 to \u003C 6 Years","Participants will be enrolled in this cohort after the safety and PK data has been evaluated for cohorts 1 and 2.\n\nParticipants will receive 0.05 mg to 0.2 mg naldemedine based on their body weight once daily for 7 days.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Naldemedine","Administered as an oral tablet (0.2 mg dose level only), or oral suspension (all dose levels)",[9,15,19],[29],"Rizmoic",[31],{"name":32,"affiliation":33,"role":34},"Shionogi Clinical Trials Administrator Clinical Support Help Line","Shionogi","STUDY_DIRECTOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","800-849-9707",null,"Shionogiclintrials-admin@shionogi.co.jp",[42,54,65,76,81,89,99,110,118,126,134,144,152,160,170,180],{"facility":43,"status":44,"city":45,"state":39,"zip":39,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":39},"University Center Mother Theresa , Hospital - Onco-hematology department","NOT_YET_RECRUITING","Tirana","Albania","AL",{"type":49,"coordinates":50},"Point",[51,52],19.81866,41.32744,{"lat":52,"lon":51},{"facility":55,"status":56,"city":57,"state":39,"zip":39,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":64,"contacts":39},"Yeolyan Hematology. , and Oncology Center -","RECRUITING","Yerevan","Armenia","AM",{"type":49,"coordinates":61},[62,63],44.5126,40.17765,{"lat":63,"lon":62},{"facility":66,"status":67,"city":68,"state":39,"zip":39,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":39},"CHU Saint-Pierre Clinical Trials Unit","COMPLETED","Brussels","Belgium","BE",{"type":49,"coordinates":72},[73,74],4.34878,50.85045,{"lat":74,"lon":73},{"facility":77,"status":67,"city":68,"state":39,"zip":39,"country":69,"countryCode":70,"cosmosGeoPoint":78,"geoPoint":80,"contacts":39},"Universitair Ziekenhuis Brussel (UZBrussel) - Department of Anesthesiology and Perioperative Medicine",{"type":49,"coordinates":79},[73,74],{"lat":74,"lon":73},{"facility":82,"status":67,"city":83,"state":39,"zip":39,"country":69,"countryCode":70,"cosmosGeoPoint":84,"geoPoint":88,"contacts":39},"University Hospitals Leuven Pediatrisch hemato-oncology","Leuven",{"type":49,"coordinates":85},[86,87],4.70093,50.87959,{"lat":87,"lon":86},{"facility":90,"status":56,"city":91,"state":39,"zip":39,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":98,"contacts":39},"University Clinical Hospital , Mostar","Mostar","Bosnia and Herzegovina","BA",{"type":49,"coordinates":95},[96,97],17.80806,43.34333,{"lat":97,"lon":96},{"facility":100,"status":67,"city":101,"state":39,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":109,"contacts":39},"Chu de Caen","Caen","14033","France","FR",{"type":49,"coordinates":106},[107,108],-0.35912,49.18585,{"lat":108,"lon":107},{"facility":111,"status":67,"city":112,"state":39,"zip":39,"country":103,"countryCode":104,"cosmosGeoPoint":113,"geoPoint":117,"contacts":39},"Hôpital Béclère Service de Pédiatrie Centre de Référence des Maladies Héréditaires du Métabolisme Hépatique (CRMHMH)","Clamart",{"type":49,"coordinates":114},[115,116],2.26692,48.80299,{"lat":116,"lon":115},{"facility":119,"status":67,"city":120,"state":39,"zip":39,"country":103,"countryCode":104,"cosmosGeoPoint":121,"geoPoint":125,"contacts":39},"Hôpital Jeanne de Flandre Antenne du CIC pédiatrique - Niveau 0 CHU de Lille","Lille",{"type":49,"coordinates":122},[123,124],3.05512,50.63391,{"lat":124,"lon":123},{"facility":127,"status":67,"city":128,"state":39,"zip":39,"country":103,"countryCode":104,"cosmosGeoPoint":129,"geoPoint":133,"contacts":39},"Hôpital Armand Trousseau Service Hématologie et Oncologie Pédiatrique","Paris",{"type":49,"coordinates":130},[131,132],2.3488,48.85341,{"lat":132,"lon":131},{"facility":135,"status":67,"city":136,"state":39,"zip":39,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":143,"contacts":39},"Instituto Nazionale dei Tumori","Milan","Italy","IT",{"type":49,"coordinates":140},[141,142],9.18951,45.46427,{"lat":142,"lon":141},{"facility":145,"status":67,"city":146,"state":39,"zip":39,"country":137,"countryCode":138,"cosmosGeoPoint":147,"geoPoint":151,"contacts":39},"Citta della Salute e della Scienza di Torino","Torino",{"type":49,"coordinates":148},[149,150],11.99138,44.88856,{"lat":150,"lon":149},{"facility":153,"status":67,"city":154,"state":39,"zip":39,"country":137,"countryCode":138,"cosmosGeoPoint":155,"geoPoint":159,"contacts":39},"Maternal and Child Health Institute IRCCS Burlo Garofolo, Pain and pediatric palliative care service","Trieste",{"type":49,"coordinates":156},[157,158],13.77678,45.64953,{"lat":158,"lon":157},{"facility":161,"status":44,"city":162,"state":39,"zip":39,"country":163,"countryCode":164,"cosmosGeoPoint":165,"geoPoint":169,"contacts":39},"National Center for Child Health and Development","Tokyo","Japan","JP",{"type":49,"coordinates":166},[167,168],139.69171,35.6895,{"lat":168,"lon":167},{"facility":171,"status":56,"city":172,"state":39,"zip":39,"country":173,"countryCode":174,"cosmosGeoPoint":175,"geoPoint":179,"contacts":39},"PHI University Clinic for Children's , Surgery","Skopje","North Macedonia","MK",{"type":49,"coordinates":176},[177,178],21.43141,41.99646,{"lat":178,"lon":177},{"facility":181,"status":56,"city":172,"state":39,"zip":39,"country":173,"countryCode":174,"cosmosGeoPoint":182,"geoPoint":184,"contacts":39},"University Clinic for Childrens Diseases , Department of Oncology, Hematology and , Malignant Hemopathy",{"type":49,"coordinates":183},[177,178],{"lat":178,"lon":177},{"type":186,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100484459","phase-1-safety-and-pharmacokinetics-study-of-naldemedine-in-paediatric-participants-receiving-opioids-100484459",false,"NCT05588323","Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids","A Phase 1\u002F2, Multicentre, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Naldemedine in Paediatric Patients Who Are Receiving or Who Are About to Receive Treatment With Opioids","Inclusion Criteria:\n\nDisease Characteristics\n\n* Participants with cancer or non-cancer pain who are receiving (or who are about to receive) acute or chronic treatment with opioids.\n* Participants with either newly diagnosed constipation, a history of constipation treated with laxatives, or are expected to develop constipation after opioid treatment.\n* Able to remain in the clinic for blood sampling for at least 12 hours following the first study intervention dose and are able to return for blood sampling at the 24-hour time point.\n\nWeight\n\n* Body mass index within approximately the 3rd to 97th percentile for their age according to the World Health Organization Child Growth Standards.\n\nExclusion Criteria:\n\nMedical Conditions\n\n* History of a gastrointestinal (GI) neoplasm or an ongoing GI-related issue or any recent (within last 1 year) or planned GI tract surgery.\n* Signs or symptoms of GI obstruction or participants with recurrent obstruction who may be at increased risk of GI perforation.\n* Inability to eat\u002Fswallow or have need of a nasogastric tube.\n* No bowel movements reported for 7 consecutive days at the time of obtaining informed consent or on the initial day of study intervention administration (Study Day 1).\n* History of more than 1 week of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 neutropenia or thrombocytopenia with clinical sequelae.\n* Participants who need mechanical ventilation.\n* Severe CTCAE Grade 3 or above hepatic or renal impairment including end-stage renal disease requiring hemodialysis, as determined by the investigator.\n* Progressive neurological disorders or potential disruption to the blood-brain barrier (for example, primary brain malignancies, central nervous system metastases, active multiple sclerosis, etc.) considering the risk of opioid withdrawal or reduced analgesia.\n\nPrior\u002FOngoing Medications\n\n* Currently receiving the first cycle of chemotherapy.\n* Previously received naldemedine.\n\nOther Exclusions\n\n\\- Positive pregnancy test for females of childbearing potential.\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria may apply.","ALL","2 Years","18 Years",{"count":198,"type":199},24,"ESTIMATED","INTERVENTIONAL",[202,203],"PHASE1","PHASE2","The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive opioids.",[206],"Opioid-Induced Constipation (OIC)","2026-04-23",{"date":209,"type":210},"2026-04-29","ACTUAL",{"date":212,"type":210},"2023-01-04",{"date":214,"type":199},"2026-06-15",{"name":33,"class":6},16]