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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03811535
Study type Interventional
Source Novo Nordisk A/S
Contact
Status Active, not recruiting
Phase Phase 3
Start date May 20, 2019
Completion date September 30, 2025

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
Completed NCT01245374 - Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents Phase 4
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
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
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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