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Clinical Trial Summary

The study compares two medicines for children with a low level of hormone to grow: somapacitan (a new medicine) given once a week and Norditropin® (a medicine doctors can already prescribe) given once a day. Researchers will test somapacitan to see how well it works, compared to the standard treatment with Norditropin®. The participants will either get Norditropin® once every day or somapacitan once every week - which treatment the participant gets is decided by chance. The participant and the study doctor will know which treatment the participant gets. The study includes a 52 week treatment period and a minimum of 30 days follow up period.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04970654
Study type Interventional
Source Novo Nordisk A/S
Contact
Status Completed
Phase Phase 3
Start date July 22, 2021
Completion date December 18, 2023

See also
  Status Clinical Trial Phase
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Completed NCT03672617 - Validation of a Questionnaire That Identifies the Reasons for Non-adherence to Existing Growth Hormone Therapy
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Completed NCT01502124 - Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency Phase 3
Completed NCT01604161 - Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome N/A
Active, not recruiting NCT03811535 - 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) Phase 3
Recruiting NCT02616562 - Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency Phase 2
Completed NCT00567385 - Liquid Somatropin Formulation in Children With Growth Hormone Deficiency Phase 4
Enrolling by invitation NCT03972345 - Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Completed NCT03186495 - Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function Phase 1
Completed NCT01500486 - Observational Study of Norditropin NordiFlex® With NordiFlex PenMateâ„¢ N/A
Completed NCT01543867 - Safety and Efficacy of Long-term Somatropin Treatment in Children N/A
Completed NCT01514500 - First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects Phase 1
Withdrawn NCT01068639 - An Observational Study on Treatment Compliance by Children Treated With Growth Hormone N/A
Completed NCT01973244 - A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency Phase 1
Completed NCT00936403 - A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone Phase 2
Completed NCT00262249 - Effect of Growth Hormone in Children With Growth Hormone Deficiency Phase 3
Completed NCT03212131 - Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function. Phase 1