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Clinical Trials in India / NCT03878446
Active, not recruiting Phase 2

A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day

NCT03878446 · tracked via the Priya Life Science India tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 2
Started
2019-07-04
Last updated
2026-08-13

Condition(s) studied

Short Stature Children Born Small for Gestational Age (SGA)

Investigational drug(s) / intervention(s)

SomapacitanNorditropin®

Somapacitan: Somapacitan injected under the skin once a week.

Norditropin®: Norditropin® injected under the skin once a day.

Study 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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
11 Years
Healthy volunteers
No
Inclusion Criteria: * Pre-pubertal children, boys: 1. age between 2.5 and 11.0 years at screening. 2. testes volume below 4 ml. * Pre-pubertal children, girls: 1. age between 2.5 and 10.0 years at screening. 2. Tanner stage 1 for breast development (no palpable glandular breast tissue). * Born small for gestational age (birth length and/or weight below -2 standard deviation scores) (according to national standards). * Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and gender at screening according to the standards of Centers for Disease Control and Prevention at screening. * Impaired height velocity defined as annualized height velocity below the 50th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening. * No prior exposure to growth hormone therapy or Insulin-like Growth Factor-I (IGF-I) treatment. Exclusion Criteria: * Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements. * Children with hormonal deficiencies including suspected or confirmed growth hormone deficiency according to local practise. * Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening. * Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 μg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening. * Concomitant administration of other treatments that may have an effect on growth, e.g but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder. * Diagnosis of attention deficit hyperactivity disorder. * Prior history or presence of malignancy including intracranial tumours.

Primary outcome measure(s)

Trial sites (95)

FacilityCityRegionStatus
Univ of AL at Birmingham_BRM Birmingham Alabama
Children's Hosp Of Orange Orange California
St. Luke's Children's Endo Boise Idaho
Univ of Minnesota M.C.H. Minneapolis Minnesota
Children's Minnesota Saint Paul Minnesota
Goryeb Children's Hospital Morristown New Jersey
Rutgers-Rwjms New Brunswick New Jersey
NYU Langone Hospital-LI Garden City New York
NYU Langone Hospital-LI Mineola New York
Icahn Sch of Med-Mt Sinai Hosp New York New York
CCHMC_Cinc Cincinnati Ohio
Univ Oklahoma Sci Ctr OK City Oklahoma City Oklahoma
Cook Children's Hospital-Hematology-Oncology Fort Worth Texas
MultiCare Inst for Res & Innov Tacoma Washington
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
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
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_Service d'Endocrinologie pédiatrique 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 Paris France
Hôpital Necker Paris France
HOPITAL DES ENFANTS-HOPITAL PAULE DE VIGUIER - Pharmacie 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
Jehangir Clinical Development Centre Pune Maharashtra
All India Institute of Medical Sciences New Dehli New Delhi
CHI Crumlin Dept of Endocrinology Dublin Ireland
Rambam MC - Department of Pediatrics A Haifa Israel

+ 55 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03878446 on ClinicalTrials.gov ↗ ← All trials in India