A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

399

Participants

Timeline

Start Date

August 10, 2022

Primary Completion Date

August 5, 2024

Study Completion Date

October 29, 2027

Conditions
SGA, Turner Syndrome, Noonan Syndrome, ISS
Interventions
DRUG

Somapacitan

Somapacitan will be administered subcutaneously (s.c.) once weekly using PDS290 pen-injector.

DRUG

Norditropin®

Norditropin® will be administered s.c. once daily using FlexPro® pen-injector.

Trial Locations (165)

1004

Children's Clinical University Hospital, Riga

1090

UZ Brussel, Brussels

1200

Cliniques Universitaires Saint-Luc - Serv. Pédiatrie, Brussels

1525

PeK - Dept. of Paediatric Endocrinology, Diabetes and Metabolism, Ljubljana

University Children's Hospital, Ljubljana

1606

"SHATPD - Prof. Ivan Mitev EAD", Sofia

1864

Department of Peadiatrics CHBAH, Johannesburg

2650

UZA - UZ Antwerpen - Kinderziekenhuis, Edegem

3000

UZ Leuven - Kindergeneeskunde, Leuven

3010

Med. Kinder- und Poliklinik, Bern

3600

Dr K Pillay's site, Westville

4002

UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics, Plovdiv

4020

Kepler Universitätsklinikum GmbH - Med Campus IV (vorm.LFKK), Linz

4058

Dr Y Ganie's site, Mayville

5800

"UMHAT Dr. Georgi Stranski Pleven", Pleven

9010

"MHAT Sveta Marina", Varna

10330

King Chulalongkorn Memorial hospital-Ped-Endocrinology, Bangkok

10400

Ramathibodi Hospital - Ped-Endo and Metabolism, Ratchathewi

Ramathibodi Hospital - Ped-Endo and Metabolism, Bangkok

PMK - Paediatrics Endocrinology Centre, Bangkok

10700

SI - Dept of Paediatrics, Bangkok

11000

University Children's Hospital Tirsova, Belgrade

11070

Institute for Mother and Child Health Care of Serbia, Belgrade

11501

NYU Langone Hospital-LI, Mineola

11530

NYU Langone Hospital-LI, Garden City

12462

"U.G.H. Attikon, Pediatric Endocrinology Outpatient Clinic", Athens

12713

King Faisal Specialist Hospital & Research Centre, Riyadh, Riyadh

13005

Assistance Publique Hopitaux de Marseille-Hopital de La Timone-2, Marseille

13385

Hopital de La Timone, Marseille Cédex 05

14812

National Guard Hospital, Riyadh

15224

UPMC Child Hosp-Pittsburgh, Pittsburgh

15706

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela

16150

Hospital Universiti Sains Malaysia_Kota Bharu, Kelantan, Kota Bharu

19803

Nemours/AI duPont Hosp-Chld, Wilmington

20132

Ospedale San Raffaele UO di Pediatria e UO di Neonatologia, Milan

21000

Institute for Health Care of Children and Adolescents, Novi Sad

26504

General University of Patra - Paediatric Department, Pátrai

27610

WakeMed Childn Endo-Dbt_Raleig, Raleigh

28660

Hospital Madrid Montepríncipe, Boadilla del Monte

30099

Chungnam National University Sejong Hospital, Sejong-si

30318

Atlanta Diabetes Associates, Atlanta

31059

CHU de Toulouse, Toulouse

Hopital Des Enfants-1, Toulouse

31096

Rambam MC - Department of Pediatrics A, Haifa

32207

Nemours Chld Clnc Jacksonville, Jacksonville

33000

Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin, Bordeaux

33076

CHU Pellegrin, Bordeaux

34000

University Clinical Centre Kragujevac, Kragujevac

39216

Univ of Mississippi Med Ctr, Jackson

40002

Srinagarind Hospital, Khon Kaen

42300

University Technology MARA (UiTM) - Sg Buloh, Bandar Puncak Alam

University Technology MARA (UiTM) - Puncak Alam, Bandar Puncak Alam Selangor Darul Ehsan

45229

CCHMC_Cinc, Cincinnati

46202

Riley Hosp for Child-Indiana U, Indianapolis

49033

Centre Hospitalier Régional Universitaire d' Angers, Angers

49100

Centre Hospitalier Universitaire D'Angers-2, Angers

49202

Schneider MC - Endrocrinology and Diabetes, Petah Tikva

50139

IRCCS Meyer Firenze, Florence

50161

Hospital of Lithuanian University of Health Sciences Kauno klinikos, Kaunas

50200

CMU - Department of Pediatrics, Chiang Mai

Department of Pediatrics, Chiang Mai, Chiang Mai

50612

Pusan National University Yangsan Hospital, Yangsan

52242

University OF Iowa, Iowa City

52621

Sheba MC - Pediatric endocrinology and adolescent diabetes clinics, Tel Litwinsky

54636

"AHEPA University General Hospital of Thessaloniki", Thessaloniki

54642

Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic, Thessaloniki

55102

Children's Minnesota, Saint Paul

55454

Univ of Minnesota M.C.H., Minneapolis

59100

University Malaya Medical Centre, Kuala Lumpur

University Malaya Medical Centre, Lembah Pantai

60596

Endokrinologikum Frankfurt, Frankfurt am Main

64108

The Children's Mercy Hospital, Kansas City

66421

Klinik für Allgemeine Pädiatrie und Neonatologie, Homburg

72190

Consultorio de Endocrinología y Pediatría, Puebla City

75015

Ap-Hp-Hopital Necker-2, Paris

Hôpital Necker, Paris

76104

Cook Children's Medical Center, Fort Worth

78231

Consano Clinical Research, LLC, Shavano Park

80045

Children's Hospital Colorado, Aurora

80138

"Università degli Studi della Campania L. Vanvitelli", Napoli

83712

St. Luke's Children's Endo, Boise

84101

Soroka MC - Pediatric Endocrinology, Beersheba

90027

Children's Hospital Los Angeles - Endocrinology, Los Angeles

92123

Rady Childrens Hosp San Diego, San Diego

94270

Ap-Hp-Hopital de Bicetre-1, Le Kremlin-Bicêtre

94275

Hopital de Bicetre_Le Kremlin-Bicetre, Le Kremlin-Bicêtre

95821

Sutter Valley Med Fdt Ped Endo, Sacramento

98405

MultiCare Inst for Res & Innov, Tacoma

100045

Beijing Children's Hospital, Capital Medical University, Beijing

110029

All India Institute of Medical Sciences, New Dehli

130021

The First Bethune Hospital of Jilin University-Pediatric, Changchun

200127

Shanghai Children's Medical Center-Endocrine Genetics and Metabolism, Shanghai

250098

Shandong Provincial Hospital-Pediatric, Jinan

410007

Hunan Children's Hospital-Child Health Center, Changsha

411001

Jehangir Clinical Development Centre, Pune

430019

Wuhan Children Hospital-Endocrine Genetics and Metabolism, Wuhan

Wuhan Children Hospital, Wuhan

430030

Tongji Hospital, Tongji Medical College of HUST-Pediatric, Wuhan

450018

Henan Children's Hospital Zhengzhou Children's Hospital-Endocrine Genetics and Metabolism, Zhengzhou

510080

The First Affiliated Hospital, Sun Yat-sen University, Guangzhou

572032

Sanya Central Hospital (Hainan Third People's Hospital)-Pediatric, Sanya

610000

Chengdu Women's and Children's Central Hospital, Chengdu

682041

Amrita Institute Of Medical Sciences & Research Centre, Kochi

7033001

Shamir MC - Cardio and Pedi, Ẕerifin

80111-2803

Ped Endo Assoc PC-G.V, Greenwood Village

20010-2978

Childrens National Medical Ctr, Washington D.C.

83404-7596

Rocky Mt Clin Res, LLC, Idaho Falls

07962

Goryeb Children's Hospital, Morristown

80810-040

Centro de Diabetes Curitiba, Curitiba

01223-001

Santa Casa Sao Paulo, São Paulo

01228-000

CPQuali Pesquisa Clínica Ltda, São Paulo

05403-000

Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP, São Paulo

K1H 8L1

Children's Hosp-East Ontario, Ottawa

10 000

"KBC Sestre Milosrdnice", Zagreb

00290

HUS Uusi lastensairaala, Helsinki

115-27

"Childrens' Hospital of Athens Agia Sofia", Goudi/Athens

P & A Kyriakou Childrens' Hospital, Goudi/Athens

546-42

'Ippokrateio' General Hospital of Thessaloniki, Thessaloniki

GR 54642

Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic, Thessaloniki

GR-54636

"AHEPA University General Hospital of Thessaloniki", Thessaloniki

Unknown

Cork University Hospital, Cork

00165

Bambin Gesù, Roma

Ospedale Pediatrico Bambino Gesu, Roma

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

Fondazione Policlinico Universitario Agostino Gemelli IRCS, Rome

813-0017

Fukuoka Children's Hospital, Fukuoka-shi, Fukuoka

650-0047

Hyogo Prefectual Kobe Children's Hospital Dept. Metab & endo, Kobe-shi, Hyogo

602-8566

Univ.HP, Kyoto Pref Univ of Medicine, Dept. of Pediatrics, Kyoto

630-8581

Nara Prefecture General Medical Center, Nara-shi, Nara

951 8520

Niigata University Medical & Dental Hospital_Pediatrics, Niigata-shi, Niigata

701-1192

Okayama Medical Center_Cardiology, Okayama-shi, Okayama

534-0021

Osaka City General Hospital, Pediatric Endocrinology and Me, Osaka

594-1101

Osaka Women's and Children's Hospital, Osaka

330-8777

Saitama Children's Medical Center, Endocrinorogy&Metabolism, Saitama-shi, Saitama

060-8648

Hokkaido University Hospital, Pediatrics, Sapporo, Hokkaido

Hokkaido University Hospital_Pediatrics, Sapporo, Hokkaido

420-8660

Shizuoka Children's Hospital, Department of Diabetes and metabolism, Shizuoka-shi, Shizuoka

113-8519

Institute of Science Tokyo Hospital_Pediatrics, Tokyo

Institute of Science Tokyo Hospital, Tokyo

157 8535

National Center for Child Health and Dev, Endo and Metabo, Tokyo

470-1192

Fujita Health University Hospital, Pediatrics, Toyoake, Aichi

3015 GD

Erasmus MC, Rotterdam

35-301

Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie, Rzeszów

80-952

UCK, Klinika Pediatrii, Diabetologii i Endokrynologii,, Gdansk

30-663

Uniwer. Szpital Dzieciecy Klinika Endokry. Dzieci i Mlodzie, Krakow

93-338

Klinika Endokrynologii i Chorób Metabolicznych, Lodz

71-252

SPSK nr 1 im Prof. T Sokolowskiego, Szczecin

41-800

Klinika Pediatrii SUM, SPSK nr 1 im. prof.S.Szyszko w Zabrzu_LOC#1, Zabrze

SPSK nr 1 im. prof.S.Szyszko w Zabrzu, Zabrze

1169-045

Unidade Local de Saúde São José EPE- Hospital D. Estefânia, Lisbon

1649-035

Centro Hospitalar Lisboa Norte, Lisbon

Unidade Local De Saude De Santa Maria E.P.E., Lisbon

4050-651

Unidade Local de Saúde de Santo António, E.P.E, Porto

4400-129

Centro Hospitalar de Vila Nova de Gaia, Vila Nova de Gaia

18 000

University Clinical Centre Nis, Niš

University Clinical Centre Nis, Niš

0181

Dr JC van Dyk's Rooms, Pretoria

05505

Asan Medical Center, Seoul

08950

Hospital Sant Joan de Déu, Esplugues de Llobregat

CB2 0QQ

Addenbrooke's Hospital_Cambridge, Cambridge

HU3 2JZ

Hull Royal Infirmary_Hull, Hull

SE1 7EH

Evelina Children's Hospital - St Thomas', London

Evelina London Children's Hospital, London

M13 9WL

Royal Manchester Children's Hospital, Manchester

SW17 0RE

St Georges Hospital, Tooting

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY