| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03831880 | Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD | PHASE3 | COMPLETED | 87 | — | — | Feb 7, 2019 | Aug 28, 2020 | Oct 14, 2021 | 32 | United States, Bulgaria +3 |
| NCT00965484 | Genotropin Study Assessing Use of Injection Pen | PHASE3 | COMPLETED | 136 | — | — | Oct 1, 2009 | Jan 1, 2010 | Jan 28, 2011 | 25 | United States |
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...