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A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
Sponsor: Novo Nordisk A/S
Summary
The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Participants will either get somapacitan or Norditropin® - which treatment is decided by chance. Both participants and the study doctor will know which treatment the participants get. The study will last for 5 years. Participants will take either an injection once every week or once every day.
Official title: A Dose-finding Trial Evaluating the Effect and Safety of Once-weekly Treatment of Somapacitan Compared to Daily Norditropin® in Children With Short Stature Born Small for Gestational Age With no Catch-up Growth by 2 Years of Age or Older
Key Details
Gender
All
Age Range
2 Years - 11 Years
Study Type
INTERVENTIONAL
Enrollment
62
Start Date
2019-07-04
Completion Date
2026-12-23
Last Updated
2025-12-23
Healthy Volunteers
No
Interventions
Somapacitan
Somapacitan injected under the skin once a week.
Norditropin®
Norditropin® injected under the skin once a day.
Locations (92)
Univ of AL at Birmingham_BRM
Birmingham, Alabama, United States
Children's Hosp Of Orange
Orange, California, United States
St. Luke's Children's Endo
Boise, Idaho, United States
Univ of Minnesota M.C.H.
Minneapolis, Minnesota, United States
Children's Minnesota
Saint Paul, Minnesota, United States
Goryeb Children's Hospital
Morristown, New Jersey, United States
Rutgers-Rwjms
New Brunswick, New Jersey, United States
NYU Langone Hospital-LI
Garden City, New York, United States
NYU Langone Hospital-LI
Mineola, New York, United States
Icahn Sch of Med-Mt Sinai Hosp
New York, New York, United States
CCHMC_Cinc
Cincinnati, Ohio, United States
Univ Oklahoma Sci Ctr OK City
Oklahoma City, Oklahoma, United States
Cook Children's Hospital-Hematology-Oncology
Fort Worth, Texas, United States
MultiCare Inst for Res & Innov
Tacoma, Washington, United States
CHU Bab El Oued Pediatrics Dept
Algiers, Algeria
Endo and Diab Dept El Oued
Algiers, Algeria
endocrino-diabetology department, Hospital IBN BADIS.
Constantine, Algeria
Kepler Universitätsklinikum GmbH - Med Campus IV (vorm.LFKK)
Linz, Upper Austria, Austria
Med. Univ. Graz -Klinische Abteilung f. Allgemeine Pädiatrie
Graz, Austria
LKH Salzburg- Univ. Klinik f. Kinder- und Jugendheilkunde
Salzburg, Austria
LKH St. Poelten, Kinder-und Jugendheilkunde
Sankt Pölten, Austria
Salzkammergut-Klinikum Vöcklabruck
Vöcklabruck, Austria
Stollery Children's Hospital
Edmonton, Alberta, Canada
Rigshospitalet Klinik for Vækst og Reproduktion Afsnit 5064
Copenhagen Ø, Denmark
Tallinn Children's Hospital
Tallinn, Estonia
Tartu University Hospital Children's Clinic
Tartu, Estonia
Centre Hospitalier Universitaire D'Angers-2
Angers, France
Ap-Hp-Hopital de Bicetre-2
Le Kremlin-Bicêtre, France
Assistance Publique Hopitaux de Marseille-Hopital de La Timone-2
Marseille, France
Hopital de La Timone
Marseille Cédex 05, France
Ap-Hp-Hopital Necker-2
Paris, France
Hôpital Necker
Paris, France
Hopital Des Enfants-2
Toulouse, France
Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő
Budapest, Hungary
Szegedi Tudományegyetem Gyermekgyógyászati Klinika
Szeged, Hungary
Amrita Institute Of Medical Sciences & Research Centre
Kochi, Kerala, India
Jehangir Clinical Development Centre
Pune, Maharashtra, India
All India Institute of Medical Sciences
New Dehli, New Delhi, India
CHI Crumlin Dept of Endocrinology
Dublin, Ireland
Rambam MC - Department of Pediatrics A
Haifa, Israel
Meir MC - Department of Paediatrics
Kfar Saba, Israel
Schneider MC - Endrocrinology and Diabetes
Petah Tikva, Israel
IRCCS Meyer Firenze
Florence, Italy
Ospedale Pediatrico Gaslini
Genova, Italy
Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia
Milan, Italy
Ospedale Pediatrico Bambino Gesu
Roma, Italy
Kurume University Hospital, Pediatrics
Fukuoka, Japan
Fukuoka Children's Hospital_Endocrinology and Metabolism
Fukuoka-shi, Fukuoka, Japan
Fukuoka Children's Hospital
Fukuoka-shi, Fukuoka, Japan
Fukuyama City Hospital_Department of Pediatrics
Fukuyama-shi, Hiroshima, Japan
Hyogo Prefectual Kobe Children's Hospital Dept. Metab & endo
Kobe-shi, Hyogo, Japan
Univ.HP, Kyoto Pref Univ of Medicine, Dept. of Pediatrics
Kyoto, Japan
Nara Prefecture General Medical Center_ Nara-shi, Nara
Nara-shi, Nara, Japan
Niigata University Medical & Dental Hospital_Pediatrics
Niigata-shi, Niigata, Japan
Osaka City General Hospital, Pediatric Endocrinology and Me
Osaka, Japan
Osaka Women's and Children's Hospital
Osaka, Japan
Saitama Children's Medical Center, Endocrinorogy&Metabolism
Saitama-shi, Saitama, Japan
Institute of Science Tokyo Hospital_Pediatrics
Tokyo, Japan
Institute of Science Tokyo Hospital
Tokyo, Japan
National Center for Child Health and Dev, Endo and Metabo
Tokyo, Japan
Keio University Hospital, Pediatrics
Tokyo, Japan
Children's Clinical University Hospital
Riga, Latvia
Haukeland Universitetssykehus, Barneklinikken
Bergen, Norway
SPSK nr 1 im Prof. T Sokolowskiego
Szczecin, Poland
Instytut ''Pomnik - Centrum Zdrowia Dziecka''
Warsaw, Poland
Republic Children's Hospital of Ministry of Health of Udmurt
Izhevsk, Russia
Setchenov First Moscow State Medical University
Moscow, Russia
RMAPE
Moscow, Russia
Children's clinical city hospital #1
Novosibirsk, Russia
FSBEI of Higher Education "Rostov State Medical University"
Rostov-on-Don, Russia
SPSBHI City Children out-patient clinic #44
Saint Petersburg, Russia
Samara Regional Children Clinical Hospital n.a. N.N. Ivanova
Samara, Russia
Siberian State Medical University
Tomsk, Russia
University Children's Hospital Tirsova
Belgrade, Serbia
Institute for Mother and Child Health Care of Serbia
Belgrade, Serbia
University Clinical Centre Kragujevac
Kragujevac, Serbia
Clinical Center in Nis
Niš, Serbia
Institute for Health Care of Children and Adolescents
Novi Sad, Serbia
Hospital Sant Joan de Déu
Esplugues Llobregat(Barcelona), Spain
Hospital Clínico de Santiago de Compostela
Santiago de Compostela, Spain
Med. Kinder- und Poliklinik
Bern, Switzerland
Kinderspital Endokrinologie, Zürich
Zurich, Switzerland
King Chulalongkorn Memorial hospital-Ped-Endocrinology
Bangkok, Thailand
King Chulalongkorn Memorial hospital_Ped-Endocrinology
Bangkok, Thailand
Phramongkutklao Hospital_Ped-Endo_Pediatrics
Bangkok, Thailand
Dnipropetrovsk Regional Children's Clinical Hospital - Endocrinology department
Dnipro, Ukraine
Kharkiv Regional Children's Clinical Hospital - Endocrinological department
Kharkiv, Ukraine
Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology
Kyiv, Ukraine
Hull Royal Infirmary_Hull
Hull, United Kingdom
Alder Hey Children's Hospital
Liverpool, United Kingdom
Royal London Hospital_London
London, United Kingdom
Royal Manchester Children's Hospital
Manchester, United Kingdom