Table of Contents
- Clinical trial overview
- Who the trials are for
- Study designs and phases
- What the trials measure
- Trial status and enrollment
- Key terms explained
Clinical trial overview
Clinical studies of Ibutamoren Mesilate are looking at children with growth hormone deficiency, including idiopathic growth hormone deficiency, which means the cause is not known.[1][2] The trials are focused on safety and growth-related results, not on a general drug description.[1][2]
Who the trials are for
One study is in children with idiopathic growth hormone deficiency, and another study was planned for prepubertal children with growth hormone deficiency who had not received treatment before.[1][2] “Prepubertal” means before puberty starts, and “naïve-to-treatment” means the children had not been treated before in this study setting.[2]
Study designs and phases
The available trials are interventional studies, which means the research team gives a study treatment and follows the results.[1][2] One trial is Phase 2 and is an extension study to monitor long-term safety, while the other was a Phase 3 study planned as multicenter, randomized, double blind, and placebo-controlled.[1][2]
A randomized study assigns participants by chance, a double blind study keeps participants and study staff from knowing who gets which treatment, and a placebo-controlled study compares the study drug with a look-alike treatment that has no active drug.[2]
What the trials measure
The Phase 2 extension study measures safety through adverse events, serious adverse events, laboratory results, and physical examination findings.[1] Adverse events are unwanted medical problems during a study, and serious adverse events are more severe problems.[1]
The Phase 3 study was designed to measure annualized height velocity from Day 1 to Month 12, which is a way to see how fast a child grows over one year.[2] This makes growth rate the main effectiveness outcome in that trial.[2]
Trial status and enrollment
One trial is authorised and includes 69 participants.[1] The Phase 3 study was withdrawn and had an enrollment target of 159 participants.[2]
Key terms explained
- Idiopathic: the cause is not known, so the condition happens without a clear reason.[1]
- Laboratory results: blood or other test results used to check health during the study.[1]
- Physical examination findings: what the study team sees or measures during a check-up.[1]
- Multicenter: the study is carried out at more than one site or clinic.[2]
- Enrollment: the number of people planned or included in a study.[1][2]
