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The aim of the study is to evaluate the E-Device performances and handling on the use in common practice, by collecting the impressions of patients, nurses and the investigator on the graphic interface, the instructions manual, the E-Device training and the material itself.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saizen® E-Device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saizen® E-Device | Device | Saizen® (recombinant human growth hormone [r-hGH]) injection 8 milligram (mg) per 137 milliliter (mL) will be administered using an electronic auto-injector (E-Device) subcutaneously (SC) in the evening as per local Summary of Product Characteristics (SmPC) for 60 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects' Overall Impression After Using E-Device | Subjects' overall impression after using E-Device was measured on a scale ranging from 1 to 3, where 1 = bad, 2 = good, and 3 = very good. Number of subjects with response based on overall impression scale were presented. | 2 Weeks |
| Usefulness and Reliability of E-Device Functions | Following functions were assessed: Display of remaining dose in cartridge, Display of last injection date and time, Automatic needle attachment, Audible and visual signals, Dose injected confirmation, Dose history, Customizable needle insertion speed, Customizable drug insertion speed, Customizable insertion depth, Teach me menu, On screen instructions, Customizable name and picture, Pre-programmed dose and Skin sensor. Usefulness and reliability of each of the E-Device functions was measured on a scale ranging from 1 to 3, where 1 = not useful, 2 = useful, and 3 = very useful. Number of subjects with response based on usefulness and reliability scale were presented. | 2 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects' Feedback Immediately After Initial Training During Inclusion Visit | Subjects' feedback immediately after initial training on the handling and use of E-Device was assessed on scale ranging from 1 to 3, where 1 = difficult, 2 = easy, and 3 = very easy. Subjects were provided training on the following aspects: Cartridge loading, Needle attachment, Needle detachment, Injection process, Navigation in the menu, and Handling of the device. Number of subjects with response based on their feedback were presented. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Lipha Santé s.a.s., an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18589398 | Result | Tauber M, Payen C, Cartault A, Jouret B, Edouard T, Roger D. User trial of Easypod, an electronic autoinjector for growth hormone. Ann Endocrinol (Paris). 2008 Dec;69(6):511-6. doi: 10.1016/j.ando.2008.04.003. Epub 2008 Jun 26. |
| Label | URL |
|---|---|
| Full FDA approved prescribing information can be found here | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Saizen® E-Device | Saizen® (recombinant human growth hormone [r-hGH]) injection 8 milligram (mg) per 137 milliliter (mL) was administered using an electronic auto-injector (E-Device) subcutaneously (SC) in the evening as per local Summary of Product Characteristics (SmPC) for 60 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Saizen® E-Device | Saizen® (recombinant human growth hormone [r-hGH]) injection 8 milligram (mg) per 137 milliliter (mL) was administered using an electronic auto-injector (E-Device) subcutaneously (SC) in the evening as per local Summary of Product Characteristics (SmPC) for 60 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjects' Overall Impression After Using E-Device | Subjects' overall impression after using E-Device was measured on a scale ranging from 1 to 3, where 1 = bad, 2 = good, and 3 = very good. Number of subjects with response based on overall impression scale were presented. | All subjects who were administered with at least 1 dose of study medication with E-Device. | Posted | Number | subjects | 2 Weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Saizen® E-Device | Saizen® (recombinant human growth hormone [r-hGH]) injection 8 milligram (mg) per 137 milliliter (mL) was administered using an electronic auto-injector (E-Device) subcutaneously (SC) in the evening as per local Summary of Product Characteristics (SmPC) for 60 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@merckgroup.com |
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| ID | Term |
|---|---|
| D006130 | Growth Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Inclusion visit (Day 1) |
| Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit | Nurse/physician's feedback was assessed for E-Device setting up and Dose programming on inclusion visit using a scale ranging from 1 to 3, where 1 = difficult, 2 = easy, and 3 = very easy. Nurse/Physician's response for the number of subjects were presented. | Inclusion visit (Day 1) |
| Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) | An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect, AEs leading to discontinuation and AEs leading to death. | Day 1 up to Day 90 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Usefulness and Reliability of E-Device Functions | Following functions were assessed: Display of remaining dose in cartridge, Display of last injection date and time, Automatic needle attachment, Audible and visual signals, Dose injected confirmation, Dose history, Customizable needle insertion speed, Customizable drug insertion speed, Customizable insertion depth, Teach me menu, On screen instructions, Customizable name and picture, Pre-programmed dose and Skin sensor. Usefulness and reliability of each of the E-Device functions was measured on a scale ranging from 1 to 3, where 1 = not useful, 2 = useful, and 3 = very useful. Number of subjects with response based on usefulness and reliability scale were presented. | All subjects who were administered with at least 1 dose of study medication with E-Device. | Posted | Number | subjects | 2 Weeks |
|
|
|
| Secondary | Subjects' Feedback Immediately After Initial Training During Inclusion Visit | Subjects' feedback immediately after initial training on the handling and use of E-Device was assessed on scale ranging from 1 to 3, where 1 = difficult, 2 = easy, and 3 = very easy. Subjects were provided training on the following aspects: Cartridge loading, Needle attachment, Needle detachment, Injection process, Navigation in the menu, and Handling of the device. Number of subjects with response based on their feedback were presented. | All subjects who were administered with at least 1 dose of study medication with E-Device. | Posted | Number | subjects | Inclusion visit (Day 1) |
|
|
|
| Secondary | Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit | Nurse/physician's feedback was assessed for E-Device setting up and Dose programming on inclusion visit using a scale ranging from 1 to 3, where 1 = difficult, 2 = easy, and 3 = very easy. Nurse/Physician's response for the number of subjects were presented. | All included subjects were analyzed who used at least 1 dose of study medication with E-Device. | Posted | Number | subjects | Inclusion visit (Day 1) |
|
|
|
| Secondary | Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) | An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect, AEs leading to discontinuation and AEs leading to death. | All subjects who were administered with at least 1 dose of study medication with E-Device. | Posted | Number | subjects | Day 1 up to Day 90 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
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| Display of last injection date/time: Not Useful |
|
| Display of last injection date/time: Useful |
|
| Display of last injection date/time: Very Useful |
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| Automatic needle attachment: Not Useful |
|
| Automatic needle attachment: Useful |
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| Automatic needle attachment: Very Useful |
|
| Audible and visual signals: Not Useful |
|
| Audible and visual signals: Useful |
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| Audible and visual signals: Very Useful |
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| Dose injected confirmation: Not Useful |
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| Dose injected confirmation: Useful |
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| Dose injected confirmation: Very Useful |
|
| Dose history: Not Useful |
|
| Dose history: Useful |
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| Dose history: Very Useful |
|
| Customizable needle insertion speed: Not Useful |
|
| Customizable needle insertion speed: Useful |
|
| Customizable needle insertion speed: Very Useful |
|
| Customizable drug insertion speed: Not Useful |
|
| Customizable drug insertion speed: Useful |
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| Customizable drug insertion speed: Very Useful |
|
| Customizable insertion depth: Not Useful |
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| Customizable insertion depth: Useful |
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| Customizable insertion depth: Very Useful |
|
| Teach me menu: Not Useful |
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| Teach me menu: Useful |
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| Teach me menu: Very Useful |
|
| On screen instructions: Not Useful |
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| On screen instructions: Useful |
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| On screen instructions: Very Useful |
|
| Customizable name and picture: Not Useful |
|
| Customizable name and picture: Useful |
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| Customizable name and picture: Very Useful |
|
| Pre-programmed dose: Not Useful |
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| Pre-programmed dose: Useful |
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| Pre-programmed dose: Very Useful |
|
| Skin sensor: Not Useful |
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| Skin sensor: Useful |
|
| Skin sensor: Very Useful |
|
| Title | Measurements |
|---|---|
|
| Needle attachment: Difficult |
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| Needle attachment: Easy |
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| Needle attachment: Very Easy |
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| Needle detachment: Difficult |
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| Needle detachment: Easy |
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| Needle detachment: Very Easy |
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| Injection process: Difficult |
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| Injection process: Easy |
|
| Injection process: Very Easy |
|
| Injection process: Missing data |
|
| Navigation in the menu: Difficult |
|
| Navigation in the menu: Easy |
|
| Navigation in the menu: Very Easy |
|
| Handling of the device: Difficult |
|
| Handling of the device: Easy |
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| Handling of the device: Very Easy |
|
| Handling of the device: Missing data |
|
| Title | Measurements |
|---|---|
|
| Dose programming: Difficult |
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| Dose programming: Easy |
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| Dose programming: Very Easy |
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| Dose programming: Missing data |
|