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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT01626833
Eligibility Criteria:
Inclusion Criteria:
* Medical screening.
* Female and male subjects aged 8-16 years and 11 months, with clinical anorexia nervosa and / or reference to the diagnostic criteria of DSM-IV (1) before or at early puberty (Tanner stage 1 or 2) and with a prolonged Catch-Down for at least 18 months (HV ≤ 2 cm / year), with bone age ≤ 12 years in girls and ≤14 years in boys.
* Anorexia nervosa diagnosed at least 1 year before the study
* Growth velocity documented for at least 18 months before inclusion
* As with any child with a severe Catch-Down an assessment of GH secretion must be performed before inclusion (in the context of care) in the trial, which is not conditioned by the GH peak value : GH value of \<20 miu / L will lead to the production of a brain MRI (in the context of care) that have to be normal (normal hypothalamic-pituitary axis and absence of tumor pathology) to allow Inclusion of the patient.
* Normal glucose tolerance
* Stable metabolic state with of weight gain of at least 10% of body weight from the time the body mass index was the lowest in relation to the occurrence of the disease and normal blood electrolytes (no hypokalemia) .
* Subjects whose holders have signed parental consent
* Subjects whose holders of parental authority are affiliated to a social security scheme
* CMU (CMU universal medical coverage).
Exclusion Criteria:
* Subjects in the mid-puberty (Tanner stage 3 or 4) or with menarche.
* Subjects with a chromosomal abnormality or other chronic disease associated chronic requiring long-term treatment.
* Impaired glucose tolerance or diabetes.
* Inability of the patient or the medical team to ensure the progress and monitoring under the protocol.
* Participation in another trial.
* Bradycardia ≤ 50 bpm.
* Children whose holders of parental authority are not beneficiaries of social security
* Contra-indication to SOMATROPINE
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
203 Months
Study:
NCT01626833
Study Brief:
Protocol Section:
NCT01626833