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NCT05330325 · ClinicalTrials.gov registry record · Phase 3
A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow
A Phase 3 study of SGA, Turner Syndrome, Noonan Syndrome, ISS, sponsored by Novo Nordisk A/S.
- Active
- Registry status
- Phase 3
- Development phase
- 412
- Enrollment target
- 20
- Study locations
NCT05330325 is a Phase 3 study of SGA, Turner Syndrome, Noonan Syndrome, ISS that is active but no longer recruiting, run by Novo Nordisk A/S. The registered enrollment target is 412 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT05330325, a Phase 3 study of SGA, Turner Syndrome, Noonan Syndrome, ISS, is active but no longer recruiting, sponsored by Novo Nordisk A/S.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 412 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for upto 5.5 years. The participants will either get somapacitan once a week up to 5.5 years or Norditropin® once a day for 1 year followed by somapacitan once a week for up to 4.5 years. Which treatment the participants get is decided by chance.
Conditions Studied
Interventions
- DRUG Somapacitan
- DRUG Norditropin®
Study Locations (20)
California
- Children's Hospital Los Angeles - Endocrinology - Los Angeles
- Sutter Valley Med Fdt Ped Endo - Sacramento
- Rady Childrens Hosp San Diego - San Diego
Colorado
- Children's Hospital Colorado - Aurora
- Rocky Mt Ped and Endo - Centennial
- Ped Endo Assoc PC-G.V - Greenwood Village
Idaho
- St. Luke's Children's Endo - Boise
- Rocky Mt Clin Res, LLC - Idaho Falls
Minnesota
- Univ of Minnesota M.C.H. - Minneapolis
- Children's Minnesota - Saint Paul
Alabama
- Univ of AL at Birmingham_BRM - Birmingham
Delaware
- Nemours/AI duPont Hosp-Chld - Wilmington
District of Columbia
- Childrens National Medical Ctr - Washington D.C.
Florida
- Nemours Chld Clnc Jacksonville - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 412 participants |
| Start Date | 2022-08-10 |
| Est. Completion | 2027-10-29 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05330325
The ClinicalTrials.gov registry entry for NCT05330325 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 412 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 1 condition, with SGA, Turner Syndrome, Noonan Syndrome, ISS appearing as the primary indexed condition, and to 2 interventions - of which Somapacitan is the first listed.
NCT05330325 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Colorado, Idaho.
Frequently Asked Questions
What is clinical trial NCT05330325 about?
NCT05330325 is a clinical study titled "A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow". The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new ...
What is the current status of trial NCT05330325?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 412 participants. The study started on 2022-08-10. Estimated completion is 2027-10-29.
What conditions does trial NCT05330325 study?
This clinical trial studies the following conditions: SGA, Turner Syndrome, Noonan Syndrome, ISS.
What interventions are being tested in trial NCT05330325?
The interventions under investigation include: Somapacitan (DRUG), Norditropin® (DRUG).
Who is sponsoring clinical trial NCT05330325?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05330325 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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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.