Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

PHASE2CompletedINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

September 26, 2024

Study Completion Date

September 26, 2024

Conditions
Growth Hormone DisorderGrowth Hormone Deficiency in Children
Interventions
DRUG

somapacitan

Administered subcutaneously (s.c., under the skin) once-weekly.

DRUG

Norditropin® FlexPro® pen

Administered subcutaneously (s.c., under the skin) once daily.

DRUG

NNC0195-0092

Administered subcutaneously (s.c., under the skin) once-weekly.

Trial Locations (54)

1090

Brussels

1525

University Children's Hospital, Ljubljana

Ljubljana

4020

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

8036

Graz

9500

Landeskrankenhaus Villach, Villach

11501

Novo Nordisk Clinical Trial Call Center, Mineola

NYU Langone Hospital-LI, Mineola

19803

Nemours/AI duPont Hosp-Chld, Wilmington

31059

Hôpital des Enfants, Toulouse

31096

Rambam Medical Center Children A Dept., Haifa

33076

CHU Pellegrin, Bordeaux

Bordeaux

34093

Istanbul

34854

Marmara University Medical Faculty, Istanbul

35056

HOPITAL SUD de RENNES, Rennes

44093

Clinique Médicale Pédiatrique, Nantes

44281

Department of Pediatrics , Meir Medical Center, Kfar Saba

Kfar Saba

45229

CCHMC_Cinc, Cincinnati

Novo Nordisk Clinical Trial Call Center, Cincinnati

49033

Centre Hospitalier Régional Universitaire d' Angers, Angers

49202

Endrocrinology & DM Schneider MC, Petah Tikva

52621

Sheba Medical Center Pediatric Endocrinology, Tel Litwinsky

55454

Novo Nordisk Clinical Trial Call Center, Minneapolis

60596

Frankfurt

Endokrinologikum Frankfurt, Frankfurt am Main

75015

Hôpital Necker, Paris

76018

Ivano-Frankivsk Regional Clinical Children Hospital, Ivano-Frankivsk

84101

Soroka Medical Center - Pediatric Endocrinology, Beersheba

89075

Deutsches Zentrum für Kinder- und Jugendgesundheit (DZKJ), Ulm

92123

Novo Nordisk Clinical Trial Call Center, San Diego

110029

All India Institute of Medical Sciences, New Dehli

New Dehli

411001

Jehangir Clinical Development Centre, Pune

682041

Amrita Institute Of Medical Sciences & Research Centre, Kochi

07962

Goryeb Children's Hospital, Morristown

Novo Nordisk Clinical Trial Call Center, Morristown

08901

Rutgers-Rwjms, New Brunswick

01228-000

CPQuali Pesquisa Clínica Ltda, São Paulo

São Paulo

830-0011

Kurume University Hospital, Pediatrics, Fukuoka

216-8511

St. Marianna University School of Medicine Hospital_Pediatrics, Kanagawa

602-8566

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

534-0021

Osaka City General Hospital, Pediatric Endocrinology and Me, Osaka

594-1101

Osaka Women's and Children's Hospital, Osaka

113-8519

Institute of Science Tokyo Hospital, Tokyo

Tokyo Medical and Dental University Hospital, Tokyo

157 8535

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

Tokyo

171 76

Astrid Lindgrens Barnsjukhus, Stockholm

Stockholm

04114

Kiev

Institute of Endocrinology and Metabolism of AMSU, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT02616562 - Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency | Biotech Hunter | Biotech Hunter