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)
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)
ClinicalTrials.gov ID: NCT03811535
Sponsor: Novo Nordisk A/S
Information provided by: Novo Nordisk A/S (Responsible Party)
Last Update Posted: 2024-08-20
Brief 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
Intervention / Treatment:
- Drug: Somapacitan
- Drug: Norditropin®
| Category | Value |
|---|---|
| Study Start (Actual) |
2019-05-20
|
| Primary Completion (Actual) |
2021-11-10
|
| Study Completion (Estimated) |
2025-09-30
|
| Enrollment (Actual) | 200 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
NN8640-4263
U1111-1207-9691 (Other Identifier) (OTHER: World Health Organization (WHO)) 2018-000231-27 (Other Identifier) (OTHER: European Medicines Agency (EudraCT)) JapicCTI-194773 (Registry Identifier) (REGISTRY: JAPIC (Japan)) |