Growth retardation secondary to inflammatory bowel disease in children
Conditions
Interventions
Trade Name: Norditropin® SimpleXx® 5mg/1.5ml
Product Name: Norditropin SimpleXx
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Somatropin
Other descriptive name: Growth Hormone
Conce
Sponsors
Royal Hospital For Sick Children, Yorkhill Division
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of IBD Height Velocity SDS of less than –0.5 over 6 months prior to study. Patients of all ages will be eligible but boys and girls with significant pubertal delay shall only be eligible after a period of treatment with sex steroids Written informed consent Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous treatment with rhGH Diabetes mellitus or history of significant glucose intolerance (fasting blood glucose>5.5mmol/l) Endocrinopathy other than GHD Bowel surgery within last 6 months Active malignancy Ongoing anti-cancer therapy Benign intracranial hypertension. Severe arterial hypertension, defined as diastolic blood pressure > 110 mmHg with or without antihypertensive treatment. Known or suspected allergy to the trial product or related products. Lactation/pregnancy or intent to become pregnant during the planned trial period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of rhGH, in children with growth failure associated with IBD;Secondary Objective: To assess changes in body composition and bone health after rhGH treatment in children with growth failure associated with IBD;Primary end point(s): Evaluation of the effect of rhGH on growth and metabolic markers assessed between baseline value and at 3 and 6 month treatment period (end point) | — |
Countries
United Kingdom
Outcome results
None listed