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A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN (REGISTERED)) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY

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Trial Profile

A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN (REGISTERED)) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Dec 2022

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At a glance

  • Drugs Somatrogon (Primary) ; Somatropin (Primary)
  • Indications Somatotropin deficiency
  • Focus Therapeutic Use
  • Sponsors Pfizer

Most Recent Events

  • 09 Nov 2022 Results assessing a responder analysis from data generated from a patient reported outcome, the Patient Life Interference (LI) questionnaire reported by patients with paediatric growth hormone deficiency (pGHD) in a phase 3 trial, to support and understand its interpretation presented at the 25th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research
  • 23 Mar 2021 Results evaluating patient and caregiver perceptions of treatment burden associated with a once weekly somatrogon SC injection schedule compared with once daily presented at the 103rd Annual Meeting of the Endocrine Society
  • 08 Oct 2020 Primary endpoint has been met. (Treatment burden assessed as the difference in mean overall Life Interference total scores between the weekly injection schedule and daily injection schedule after each treatment schedule experience.), according to a Pfizer media release.

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