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:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT02273804
Eligibility Criteria:
Inclusion Criteria:
* 9-17 years old
* Body Mass Index Z-score ≥ 4 SD of French reference
* Weight at enrolment ≥ 50 kg
* Therapeutic failure \> 6 months
* For girls of childbearing age, willing to have an acceptable method of contraception (no estrogens plus progestin)
* Negative pregnancy test for girls of childbearing age
* Agreeing to participate upon written informed consent
* Appropriate understanding of the study
Exclusion Criteria:
* Syndromic or secondary obesity
* Major neurological or psychiatric disorder
* Current or history of suicidal thought/attempts
* Current or history of breakdown
* Previous bariatric surgery
* Severe hypercapnia
* Renal dysfunction
* Deformity in the urinary tract or solitary kidney
* History of renal lithiasis or glaucoma
* Poorly controlled diabetic children or adolescents (HbA1c \>10%) and diabetic patients treated with Metformine and/or glibenclamide
* Hepatic dysfunction
* Bicarbonate ≤16 mmol/L
* Known hypersensitivity to the active substance or to one of the excipients
* Intolerance to saccharose
* Enrolment in another therapeutic study
* High probability to fail to comply with treatment
* Females: Pregnant, planning to become pregnant
* No signature on consent form
* Uncovered by the French National health Insurance system (Sécurité sociale)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Years
Maximum Age:
17 Years
Study:
NCT02273804
Study Brief:
Protocol Section:
NCT02273804