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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT00399893
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of PWS confirmed by chromosome analysis
* Ages 5 years to 21 years
* BMI for age ≥ (greater-than or equal to)85th percentile
* Written informed consent and assent obtained and willingness to comply with the study schedule and procedures
* Free T4, Thyroid stimulating hormone (TSH) values in the normal range (either endogenous or with thyroxine replacement)
Exclusion Criteria:
* Patients with any other clinically significant disease that would have an impact on body composition, including diabetes mellitus, chronic inflammatory bowel disease, chronic severe liver or kidney disease or neurologic disorders
* Concomitant use of an investigational drug or Octreotide in the past year
* Use of steroids for longer than 7 days within the past 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
21 Years
Study:
NCT00399893
Study Brief:
Protocol Section:
NCT00399893