Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03811535 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
NCT03811535 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 200 participants.
The verdict
NCT03811535, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
Study 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.
Interventions
- DRUG Somapacitan
- DRUG Norditropin®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2019-05-20 |
| Est. Completion | 2025-09-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03811535
The ClinicalTrials.gov registry entry for NCT03811535 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Somapacitan is the first listed.
NCT03811535 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03811535 about?
NCT03811535 is a clinical study titled "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)". 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 soma...
What is the current status of trial NCT03811535?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2019-05-20. Estimated completion is 2025-09-30.
What interventions are being tested in trial NCT03811535?
The interventions under investigation include: Somapacitan (DRUG), Norditropin® (DRUG).
Who is sponsoring clinical trial NCT03811535?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.