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A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)
Sponsor: Novo Nordisk A/S
Summary
The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Researchers will test to see how well somapacitan works. The study will also test if somapacitan is safe. Participants will either get somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both participants and the study doctor will know which treatment participants get. The study will last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the study doctor.
Official title: A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency
Key Details
Gender
All
Age Range
Any - 11 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2019-05-20
Completion Date
2025-09-30
Last Updated
2026-05-22
Healthy Volunteers
No
Conditions
Interventions
Somapacitan
Somapacitan will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight.
Norditropin®
Norditropin® will be administered s.c. once daily by FlexPro® pen-injector. Norditropin® should be injected daily in the evening. The dose will be calculated based on the subject's current body weight.
Locations (135)
Univ of AL at Birmingham_BRM
Birmingham, Alabama, United States
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
Children's Hosp Of Orange
Orange, California, United States
Sutter Valley Med Fdt Ped Endo
Sacramento, California, United States
Rocky Mt Ped and Endo
Centennial, Colorado, United States
Ped Endo Assoc PC-G.V
Greenwood Village, Colorado, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
A.I. duPont Hospital for Children/Nemours
Wilmington, Delaware, United States
Pediatric Endocrine & Wellness Center
Aventura, Florida, United States
Van Meter Pediatric Endo PC
Atlanta, Georgia, United States
Riley Hospital For Children
Indianapolis, Indiana, United States
University OF Iowa
Iowa City, Iowa, United States
Univ of Minnesota M.C.H.
Minneapolis, Minnesota, United States
Children's Minnesota
Saint Paul, Minnesota, United States
Children's Mercy Clinics
Kansas City, Missouri, United States
The Docs
Las Vegas, Nevada, United States
Goryeb Children's Hospital
Morristown, New Jersey, United States
UBMD Peds-Div of Endo/Diabetes
Buffalo, New York, United States
NYU Langone Hospital-LI
Mineola, New York, United States
WakeMed Childn Endo-Dbt_Raleig
Raleigh, North Carolina, United States
CCHMC_Cinc
Cincinnati, Ohio, United States
Univ Oklahoma Sci Ctr OK City
Oklahoma City, Oklahoma, United States
UPMC Child Hosp-Pittsburgh
Pittsburgh, Pennsylvania, United States
Dell Children's Medical Center
Austin, Texas, United States
Cook Children's Medical Center
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
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
Mntrl Chldrn Hsptl PedEndoMUHC
Montreal, Quebec, 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
Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin
Bordeaux, France
Ap-Hp-Hopital de Bicetre-1
Le Kremlin-Bicêtre, France
Hopital de Bicetre_Le Kremlin-Bicetre
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
HOPITAL DES ENFANTS-HOPITAL PAULE DE VIGUIER - Pharmacie
Toulouse, France
Endokrinologikum Frankfurt
Frankfurt am Main, Germany
Auf der Bult Medizinisches Versorgungszentrum Hannover
Hanover, Germany
Uniklinik Tübingen - Kinder- und Jugendmedizin
Tübingen, Germany
Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ)
Ulm, Germany
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
Shamir MC - Pediatric and Adolescents Endocrinology unit
Ẕerifin, 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
National Hospital Organization FUKUYAMA MEDICAL CENTER
Fukuyama-shi, Hiroshima, Japan
Fukuyama City Hospital_Department of Pediatrics
Fukuyama-shi, Hiroshima, Japan
Kanagawa Children's Medical Center, Dev. Endo and Metabo
Kanagawa, 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
Ibaraki Children's Hospital_General Pediatrics
Mito, Ibaraki, Japan
Nara Prefecture General Medical Center_ Nara-shi, Nara
Nara-shi, Nara, Japan
Niigata University Medical & Dental Hospital_Pediatrics
Niigata-shi, Niigata, Japan
Aichi Children's Health and Medical Center
Obu-shi, Aichi, Japan
Okayama Medical Center_Cardiology
Okayama-shi, Okayama, 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
Hamamatsu Univ. School of Medicine Hospital, Pediatrics
Shizuoka, Japan
Osaka University Hospital_Pediatrics
Suita-shi, Osaka, Japan
Institute of Science Tokyo Hospital_Pediatrics
Tokyo, Japan
KOUJIYA Kodomo Clinic
Tokyo, Japan
National Center for Child Health and Dev, Endo and Metabo
Tokyo, Japan
Tanaka Growth Clinic
Tokyo, Japan
Keio University Hospital, Pediatrics
Tokyo, Japan
Tokyo Metropolitan Children's Medical Center_Endo and Metab
Tokyo, Japan
Children's Clinical University Hospital
Riga, Latvia
Haukeland Universitetssykehus, Barneklinikken
Bergen, Norway
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
Rzeszów, Podkarpackie Voivodeship, Poland
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