Trials / Completed
CompletedNCT03811535
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 Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- All
- Age
- 11 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Somapacitan | Somapacitan will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight. |
| DRUG | Norditropin® | Norditropin® will be administered s.c. once daily by FlexPro® pen-injector. Norditropin® should be injected daily in the evening. The dose will be calculated based on the subject's current body weight. |
Timeline
- Start date
- 2019-05-20
- Primary completion
- 2021-11-10
- Completion
- 2025-09-30
- First posted
- 2019-01-22
- Last updated
- 2026-01-06
- Results posted
- 2023-08-04
Locations
135 sites across 26 countries: United States, Algeria, Austria, Canada, Denmark, Estonia, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Norway, Poland, Russia, Serbia, Slovenia, South Korea, Spain, Switzerland, Thailand, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03811535. Inclusion in this directory is not an endorsement.