Octreotide Therapy in Children and Young Adults With Prader-Willi Syndrome (PWS) (NCT00399893) | Clinical Trial Compass
TerminatedNot Applicable
Octreotide Therapy in Children and Young Adults With Prader-Willi Syndrome (PWS)
Stopped: Inadequate recruitment
United States5 participantsStarted 2006-12
Plain-language summary
The purpose of this study is to investigate over a 6 month period the effect of octreotide therapy on food intake, sense of hunger, body weight, body composition, efficiency of burning calories, biomarkers of weight regulation and growth hormone markers in children and young Adults with Prader-Willi Syndrome(PWS).
Who can participate
Age range
5 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Decrease in Fasting Total Ghrelin
Timeframe: 6 months
2
Number of Participants With Decrease in Weight From Baseline to 6 Months
Timeframe: 6 months
3
Number of Participants With Decreased BMI Z-score From Baseline to 6 Months
Timeframe: 6 months
4
Number of Participants With Decreased Skin-fold Measurements From Baseline to 6 Months
Timeframe: 6 months
5
Number of Participants With Decrease in Hunger and Food Intake
Timeframe: 6 months
6
Number of Participants With Improved Insulin Regulation From Baseline to 6 Months
Timeframe: 6 months
7
Number of Participants With Improved Adiponectin Regulation From Baseline to 6 Months