A research study to compare somapacitan once a week with Norditropin® once a day in children who need help to grow
- Conditions
- Children with short stature either born small for gestational age or with Turner syndrome, Noonan syndrome, or idiopathic short statureTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- CTIS2023-506927-27-00
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 407
No prior exposure to growth promoting therapy, including but not limited to growth hormone, IGF-I and ghrelin analogues., Applicable to children with SGA: Born small for gestational age (birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards). Japan: Please see local requirements in Appendix 11 (Section ?10.11)., Applicable to children with SGA: Prebubertal Children: a) Boys: - Age above er equal to 2 years and 26 weeks and below 11.0 years at screening. - Testis volume below 4 mL b) Girls: - Age above or equal to 2 years and 26 weeks and below 10.0 years at screening. Tanner stage 1 for breast development: No palpable glandular breast tissue, Applicable to girls with TS: Confirmed diagnosis of TS: CCI United Kingdom: Please see local requirements in Appendix 11 (Section ?10.11)., Applicable to girls with TS: Prepubertal girls: - Age above or equal to 2 years and 26 weeks and below 10.0 years at screening. - Tanner stage 1 for breast development: No palpable glandular breast tissue), Applicable to children with NS: Clinical diagnosis of NS according to van der Burgt score list (See Table 7) Japan: Please see local requirements in Appendix 11 (Section ?10.11)., Applicable to children with NS: Prepubertal children: a) Boys: - Age above or equal to 2 years and 26 weeks and below 11.0 years at screening. - Testis volume below 4mL b) Girls: - Age above or equal to 2 years and 26 weeks and below 10.0 years at screening. -Tanner stage 1 for breast development: No palpable glandular breast tissue, Applicable to children with ISS: Prepubertal children: a) Boys: - Age above or equal to 2 years and 26 weeks and below 11.0 years at screening. - Testis volume below 4mL b) Girls: - Age above or equal to 2 years and 26 weeks and below 10.0 years at screening. -Tanner stage 1 for breast development: No palpable glandular breast tissue, Applicable to children with ISS: Bone age: a) Boys: - Bone age below or equal to 12 years. - Bone age not delayed or advanced mor than 2 years compared to chronological age. b) Girls: - Bone age below or equal to 11 years - Bone age not delayed or advanced more than 2 years compared to chronological age.
Children with suspected or confirmed growth hormone deficiency according to local practice., Children diagnosed with diabetes mellitus or screening values from the central laboratory of a. fasting plasma glucose above or equal to 126 mg/dL (7.0 mmol/L) or b. HbA1c above or equal to 6.5%., Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method