Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
New Genotropin Pen · 2 trials · 2 indications
Participants were assessed for their treatment burden using DCOA 1 questionnaire completed by participant/caregiver dyads. The participant life interference questionnaire component of the DCOA 1 had 7 questions (life interference \[5 questions\]: a measure of life interference \[daily activities/social activities/leisure/night away from home/travel\]; life interference-changes to life routine \[1 question\]: a measure of how often changes are made to life routine; and life interference-bother of growth hormone \[GH\] injections \[1 question\]: a measure of how often the growth hormone injections cause bother) and all questions used a 5-point scale: 1= never, 2= rarely, 3= sometimes, 4= often, 5= always. The overall life interference total score was sum of all 7 questions, scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant less life interference (better outcome).
Participants were assessed for their treatment burden using DCOA 1 questionnaire completed by participant/caregiver dyads. The participant life interference questionnaire component of the DCOA 1 had 7 questions (life interference \[5 questions\]: a measure of life interference \[daily activities/social activities/leisure/night away from home/travel\]; life interference-changes to life routine \[1 question\]: a measure of how often changes are made to life routine; and life interference-bother of growth hormone \[GH\] injections \[1 question\]: a measure of how often the growth hormone injections cause bother) and all questions used a 5-point scale: 1= never, 2= rarely, 3= sometimes, 4= often, 5= always. The overall life interference total score was sum of all 7 questions, scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant less life interference (better outcome).
Participants were assessed for their treatment burden using DCOA 1 questionnaire completed by participant/caregiver dyads. The participant life interference questionnaire component of the DCOA 1 had 7 questions (life interference \[5 questions\]: a measure of life interference \[daily activities/social activities/leisure/night away from home/travel\]; life interference-changes to life routine \[1 question\]: a measure of how often changes are made to life routine; and life interference-bother of growth hormone \[GH\] injections \[1 question\]: a measure of how often the growth hormone injections cause bother) and all questions used a 5-point scale: 1= never, 2= rarely, 3= sometimes, 4= often, 5= always. The overall life interference total score was sum of all 7 questions, scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant less life interference (better outcome).
Participants were assessed for their treatment burden using DCOA 1 questionnaire completed by participant/caregiver dyads. The participant life interference questionnaire component of the DCOA 1 had 7 questions (life interference \[5 questions\]: a measure of life interference \[daily activities/social activities/leisure/night away from home/travel\]; life interference-changes to life routine \[1 question\]: a measure of how often changes are made to life routine; and life interference-bother of growth hormone \[GH\] injections \[1 question\]: a measure of how often the growth hormone injections cause bother) and all questions used a 5-point scale: 1= never, 2= rarely, 3= sometimes, 4= often, 5= always. The overall life interference total score was sum of all 7 questions, scores were transformed from raw scores and converted to a 0 to 100 scale; a lower score meant less life interference (better outcome).
Ease of use measured using the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool (based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).
| Arm | Type | Description |
|---|---|---|
| Daily to Weekly | OTHER | Genotropin to somatrogon |
| Weekly to Daily | OTHER | somatrogon to Genotropin |
| Genotropin pen | EXPERIMENTAL | All subjects will receive genotropin pen to use for 2 months. |
| Name | Type | Description |
|---|---|---|
| Genotropin | DRUG | Genotropin (dose \[mg\] at time of enrollment) given subcutaneously once daily |
| somatrogon | DRUG | 0.66 mg/kg/week given subcutaneously once weekly |
| New Genotropin Pen | DEVICE | Subjects will use the genotropin pen for 2 months. After 2 months patients and caregiver will be asked to fill out a questionnaire to assess perception of the genotropin pen |
Inclusion Criteria: 1. Children aged 3 years old and \<18 years with either isolated GHD, or GH insufficiency. 2. Currently on treatment with either Genotropin Pen®, Genotropin GoQuick Pen®, HumatroPen® (United States of America \[USA\] only), or Omnitrope® Pen (USA only) ≥3 months and have been co...
Genotropin is used for growth disorders, growth hormone deficiency, and idiopathic short stature. It is an endocrine therapy being developed by Pfizer, Inc. for conditions related to growth in children. The drug is currently in Phase 3 clinical development and is not yet approved by the FDA.
Genotropin is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the drug's safety and efficacy in treating growth-related conditions.
Genotropin is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. Pfizer has completed multiple Phase 3 trials studying its use in children with growth hormone deficiency and idiopathic short stature.
Genotropin has been studied in several completed clinical trials. NCT00396097 evaluated individualized treatment in 316 children with idiopathic short stature. NCT00965484 assessed an injection pen in 136 patients with growth hormone deficiency or idiopathic short stature. NCT03831880 compared treatment burden in 87 children with growth hormone deficiency.
Genotropin is a brand name for somatropin, which is a recombinant human growth hormone. In clinical trials, it is referred to as Genotropin (somatropin), indicating that somatropin is the active ingredient. The drug is being studied for its effects on growth in children with various growth disorders.