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NCT03878446 · ClinicalTrials.gov registry record · Phase 2

A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day

A Phase 2 study of Short Stature Children Born Small for Gestational Age (SGA), sponsored by Novo Nordisk A/S.

Active
Registry status
Phase 2
Development phase
62
Enrollment target
20
Study locations

NCT03878446 is a Phase 2 study of Short Stature Children Born Small for Gestational Age (SGA) that is active but no longer recruiting, run by Novo Nordisk A/S. The registered enrollment target is 62 participants. The trial reports 20 study locations across 12 states.

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The verdict

NCT03878446, a Phase 2 study of Short Stature Children Born Small for Gestational Age (SGA), is active but no longer recruiting, sponsored by Novo Nordisk A/S.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
62 participants
Enrollment target
20
Study locations

Study Summary

The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Participants will either get somapacitan or Norditropin® - which treatment is decided by chance. Both participants and the study doctor will know which treatment the participants get. The study will last for 5 years. Participants will take either an injection once every week or once every day.

Interventions

  • DRUG Somapacitan
  • DRUG Norditropin®

Study Locations (20)

Other

  • CHU Bab El Oued Pediatrics Dept - Algiers
  • Endo and Diab Dept El Oued - Algiers
  • endocrino-diabetology department, Hospital IBN BADIS. - Constantine
  • Med. Univ. Graz -Klinische Abteilung f. Allgemeine Pädiatrie - Graz
  • LKH Salzburg- Univ. Klinik f. Kinder- und Jugendheilkunde - Salzburg

New York

  • NYU Langone Hospital-LI - Garden City
  • NYU Langone Hospital-LI - Mineola
  • Icahn Sch of Med-Mt Sinai Hosp - New York

Minnesota

  • Univ of Minnesota M.C.H. - Minneapolis
  • Children's Minnesota - Saint Paul

New Jersey

  • Goryeb Children's Hospital - Morristown
  • Rutgers-Rwjms - New Brunswick

Alabama

  • Univ of AL at Birmingham_BRM - Birmingham

California

  • Children's Hosp Of Orange - Orange

Idaho

  • St. Luke's Children's Endo - Boise

Ohio

  • CCHMC_Cinc - Cincinnati

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2019-07-04
Est. Completion 2026-12-23
Phase Phase 2

Sponsor

Novo Nordisk A/S

431 total trials

What the Registry Record Tells You About NCT03878446

The ClinicalTrials.gov registry entry for NCT03878446 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 62 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 Short Stature Children Born Small for Gestational Age (SGA) appearing as the primary indexed condition, and to 2 interventions - of which Somapacitan is the first listed.

NCT03878446 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, New York, Minnesota.

Frequently Asked Questions

What is clinical trial NCT03878446 about?

NCT03878446 is a clinical study titled "A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day". The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Participants will either get somapacitan or Norditropin® - which ...

What is the current status of trial NCT03878446?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2019-07-04. Estimated completion is 2026-12-23.

What conditions does trial NCT03878446 study?

This clinical trial studies the following conditions: Short Stature Children Born Small for Gestational Age (SGA).

What interventions are being tested in trial NCT03878446?

The interventions under investigation include: Somapacitan (DRUG), Norditropin® (DRUG).

Who is sponsoring clinical trial NCT03878446?

This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03878446 being conducted?

This trial has 20 study locations across Alabama, California, Idaho, Minnesota, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.