NCT01578135 is a clinical trial of somatropin in Growth Disorder, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT01578135?

NCT01578135 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT01578135?

Interventions in NCT01578135: somatropin, somatropin.

What condition does NCT01578135 study?

NCT01578135 studies Growth Disorder, Small for Gestational Age.

Is NCT01578135 still recruiting?

NCT01578135 is currently completed. Last updated 20 October 2022.

Last reviewed 2022-10-20 · How we verify

NCT01578135

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

French National Registry of Children Born Small for Gestational Age Treated With Somatropin

Completed Last updated 20 October 2022

What this trial tests

trial testing somatropin in Growth Disorder in 291 participants. Completed in 9 October 2018.

Timeline

18 March 2007

Primary endpoint
9 October 2018

9 October 2018

Quick facts

Lead sponsor	Novo Nordisk A/S
Status	Completed
Study type	OBSERVATIONAL
Enrollment	291
Start date	18 March 2007
Primary completion	9 October 2018
Estimated completion	9 October 2018
Sites	1 location across France

Drugs / interventions tested

somatropin (Somatropin) — full drug profile →
somatropin (Somatropin) — full drug profile →

Conditions studied

Growth Disorder — all drugs for Growth Disorder →
Small for Gestational Age — all drugs for Small for Gestational Age →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Eligibility, any sex, with Growth Disorder or Small for Gestational Age. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is conducted in Europe. The aim of the study is to describe the patient population and therapeutic practices (study phase I), assess efficacy on growth and adult height and assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II)

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Growth Hormone Dose Modulation and Final Height in Short Children Born Small for Gestational Age: French Real-Life Data.
Coutant R, Leheup B, Nicolino M, Salles JP. · · 2023 · cited 5× · PMID 37040726 · DOI 10.1159/000530572
Determinants of adverse event occurrence in children with short stature born small for gestational age treated with growth hormone.
Coutant R, Benchikh N, Linglart A, Nicolino M, et al · · 2025 · PMID 41347137 · DOI 10.3389/fendo.2025.1656966
Abstract 7: Use of growth hormone therapy in short patients born small for gestational age: Data from real-life French clinical practice
· 2022

Verify or expand the search:

Other trials of somatropin

Trials testing the same drug.

NCT02726542 — Augmenting Growth Hormone to Ameliorate Nonalcoholic Fatty Liver Disease in Adolescents · EARLY_PHASE1 · completed
NCT02382939 — A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Prev · Phase 3 · completed
NCT02229851 — Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropi · Phase 3 · completed
NCT02092077 — A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children · Phase 2 · terminated
NCT01973244 — A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth · Phase 1 · completed

Other recruiting trials for Growth Disorder

Currently open trials in the same condition.

NCT02769975 — Evaluation of Children With Endocrine and Metabolic-Related Conditions · recruiting

Other Novo Nordisk A/S trials

Trials by the same sponsor.

NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01578135 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
Last refreshed: 20 October 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01578135.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing