A research study in children with low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day
- Conditions
- Growth Hormone Deficiency in childrenTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- CTIS2023-506829-11-00
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
Prepubertal children: a) Boys: o Age = 2 years and 26 weeks and < 11.0 years at screening oTestis volume < 4 ml b)Girls: o Age = 2 years and 26 weeks and <10.0 years at screening o Tanner stage 1 for breast development (no palpable glandular breast tissue), Confirmed diagnosis of growth hormone deficiency determined by two different growth hormone stimulation tests performed within 12 months prior to randomisation, defined as a peak growth hormone level of = 10.0 ng/ml using the WHO International Somatropin 98/574 standard, Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and gender at screening according to the standards of Center for Disease Control and Prevention, Impaired height velocity, defined as annualised height velocity below the 25th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening, Insulin-like Growth Factor-I < -1.0 Standard Deviation Score at screening, compared to age and gender normalized range measured at central laboratory, No prior exposure to growth hormone therapy or Insulin-like Growth Factor-I (IGF-I) treatment
Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements, Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening, Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 µg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening, Diagnosis of attention deficit hyperactivity disorder, Concomitant administration of other treatments that may have an effect on growth, e.g but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder, Prior history or presence of malignancy including intracranial tumours
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effect of somapacitan vs Norditropin® on longitudinal growth in children with growth hormone deficiency;Secondary Objective: To compare the safety of somapacitan vs Norditropin® in children with growth hormone deficiency;Primary end point(s): Endpoint title: Height velocity Time frame: From baseline (week 0) to visit 7 (week 52) Unit: cm/year
- Secondary Outcome Measures
Name Time Method