Ease of use and preference for a new disposable self-injection pen compared with a reusable pen for administering recombinant human growth hormone: A multicenter, 2-month, single-arm, open-label clinical trial in patient-caregiver dyads.

What Was Tested

The paper reports a study of Exogenous HGH, sermorelin & older GHRPs (why they're passed over), published as a clinical trial.

This study compared ease of use and preference for a new disposable rhGH injection pen relative to previous experience with the currently available reusable pen in standard practice.

Both pens deliver the same formulation of rhGH.

Who Took Part

The age groups tagged for this paper are children and adults, men only.

This multicenter, single-arm, open-label study assessed ease of use and preference for the 2 injection pens in patient-caregiver dyads.

Eligible children were aged 8 through 18 years, were currently being treated with rhGH, and had been compliant with use of the current reusable pen for ≥ 3 months before study entry.

How the Study Was Run

The researchers set it up as an open-label and multicenter study.

Being open-label, the Exogenous HGH, sermorelin & older GHRPs (why they're passed over) study did not mask who received what.

Running at several centres spread the Exogenous HGH, sermorelin & older GHRPs (why they're passed over) study over different clinics and patient groups.

The primary end point was the proportion of dyads who rated the new pen as no different or easier to use than the current pen.

Regardless of treatment or suspected causal relationship to the investigational product, all observed or volunteered adverse events (AEs) were recorded and rated as mild, moderate, or severe.

What Was Measured

The subject headings attached to it are Caregivers, Disposable Equipment, Drug Delivery Systems, Equipment Design, Equipment Reuse, Human Growth Hormone and Parent-Child Relations.

What This Means in Plain Language

The paper is an open-label and multicenter study of Exogenous HGH, sermorelin & older GHRPs (why they're passed over).

Results are reported in around 12 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2010 (Clinical therapeutics), a journal based in United States.

More context: the Exogenous HGH, sermorelin & older GHRPs (why they're passed over) compound page, all human trials.