Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature (NCT00191074) | Clinical Trial Compass
CompletedPhase 3
Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature
United States11 participantsStarted 2001-02
Plain-language summary
After approval of amendment (g), patients who were still receiving study drug at the time were scheduled for a study visit. In addition, patients who had discontinued early from the core, blinded phase of the study were contacted.
All of these patients were offered the opportunity to enter the unblinded extension phase (if they met eligibility criteria) and continue somatropin treatment (regardless of initial treatment randomization) until they reached final height.
Who can participate
Age range
9 Years – 16 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:
Participation in core, blinded phase and ability to be contacted by investigators.
For patients who were on treatment at the time of amendment (g), growth velocity greater than or equal to 1.5 cm/year measured over the prior 12-month period. For patients who had chosen to discontinue treatment in the core, blinded phase, bone age less than or equal to 16 years for boys and less than or equal to 14 years for girls.
Exclusion Criteria:
Diabetes mellitus.
History, evidence or signs of active malignancy within 5 years prior to the start of the extension phase.
Any condition or medication that, in the opinion of the investigators, might significantly increase the risk or decrease the efficacy of growth hormone therapy.
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
Every 6 months: physical exam, pubertal staging, height, weight, and adverse event collection.
2
Every year: arm span measurements, head circumference measurements, x-ray for bone age, and