Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT01351818
Eligibility Criteria:
Inclusion Criteria:
* Children of both sexes aged from 5 to 12 years, Tanner stage 1, with no signs of imminent pubertal development. Amenable to treatment with recombinant somatropin in the approved indication of low growth due to GH deficiency
* Selection of recombinant somatropin by the physician in the treatment authorization request, and subsequent approval of such treatment by the relevant growth hormone committee
* Body Mass Index (BMI) within ±1 SD
Exclusion Criteria:
* Children with any of the reported contraindications for treatment with recombinant somatropin, existence of active neoplasms, progression or recurrence of intracranial lesion, etc. will not be studied
* Diabetes mellitus
* Intestinal inflammatory disease
* Celiac disease
* Uncontrolled hyperthyroidism
* AIDS
* Other diseases causing chronic malabsorption, hypercatabolism or malnutrition conditions
* Chronic liver disease
* Eating disorders: anorexia, bulimia, etc
* Long-term treatment with anti-obesity drugs or drugs causing malabsorption
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
12 Years
Study:
NCT01351818
Study Brief:
Protocol Section:
NCT01351818