Genotropin Study Assessing Use of Injection Pe
- Conditions
- Idiopathic Short Stature (ISS)Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2014-004173-16-Outside-EU/EEA
- Lead Sponsor
- Pfizer, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 130
1.Age greater than or equal to (>=8) years and less than or equal to (<=) 18 years.
2.Subjects who are currently on treatment with Genotropin Pen? >=3 months.
3.Subjects who are compliant with current Genotropin Pen? treatment.
4.Written informed consent of the adult member of the subject dyad or legally authorized representative (that is (i.e.), Parent/Legal Guardian) indicating that the subject and the legally acceptable representative have been informed of all pertinent aspects of the study. In addition if possible, assent should be obtained from the child to take part in the study. The adult member of the dyad will be consenting for his/her participation.
5.The adult member of the dyad needs to be able to read English and both members of the dyad need be able to understand English.
6.Subject dyads who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
7.Female Genotropin users of child bearing potential must have a negative urine pregnancy test at screening.
Are the trial subjects under 18? yes
Number of subjects for this age range: 136
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Subjects with Prader-Willi syndrome or chronic renal insufficiency.
2.Subjects and caregivers who have been, in the opinion of the investigator,
3.non-compliant with Genotropin treatment or are not able to adequately participate in the study.
4.Subjects with chronic systemic disorders, such as diabetes and heart disease.
5.Subjects who are not able to understand written and/or verbal instructions on the proper use of grown hormone injection devices.
6.Subjects who are not able to able or willing to complete the questionnaires used for the study assessments.
7.Subjects using other growth hormone injection devices other than the current
8.Genotropin Pen?.
9.Subjects who previously participated in any of the Genotropin Mark VII or Injection Pen Assessment Questionnaire (IPAQ) development research and studies.
10.Subjects who are participating in any interventional clinical studies.
11.Subjects who are taking concomitant investigational drugs/treatment.
12.Subjects who, in the opinion of the investigator, are not likely to comply with the study requirements for any reason.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the ease of use/convenience as determined by a subject/caregiver dyad self-assessment of ease of use of the new Genotropin Mark VII pen compared to pre-study experience with the Genotropin Pen?.;Secondary Objective: To evaluate the subject/caregiver dyad preference for the new Genotropin Mark VII pen compared to pre-study experience with the Genotropin Pen?.;Primary end point(s): Percentage of Dyads (Subjects and Caregiver or Parent) Reporting no Difference or Easier to Use for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®;Timepoint(s) of evaluation of this end point: 2 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Percentage of Dyads Reporting no Preference or Preference for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®<br>2) Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Easier to Use Compared to Pre-study Experience With the Genotropin Pen®<br>3) Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen®;Timepoint(s) of evaluation of this end point: 1) 2 months <br>2) 2 months <br>3)2 months <br>