Trial Outcomes & Findings for Saizen® E-Device User Trial (NCT NCT00450190)
NCT ID: NCT00450190
Last Updated: 2018-07-23
Results Overview
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.
COMPLETED
PHASE3
20 participants
2 Weeks
2018-07-23
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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18
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
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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Overall Study
Withdrawal by Subject
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2
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Baseline Characteristics
Saizen® E-Device User Trial
Baseline characteristics by cohort
| Measure |
Saizen® E-Device
n=20 Participants
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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Age, Continuous
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11.30 years
STANDARD_DEVIATION 2.66 • n=5 Participants
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Sex: Female, Male
Female
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10 Participants
n=5 Participants
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Sex: Female, Male
Male
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10 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 2 WeeksPopulation: All subjects who were administered with at least 1 dose of study medication with 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.
Outcome measures
| Measure |
Saizen® E-Device
n=20 Participants
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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|---|---|
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Subjects' Overall Impression After Using E-Device
Good
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7 subjects
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Subjects' Overall Impression After Using E-Device
Bad
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0 subjects
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Subjects' Overall Impression After Using E-Device
Very Good
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13 subjects
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PRIMARY outcome
Timeframe: 2 WeeksPopulation: All subjects who were administered with at least 1 dose of study medication with E-Device.
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.
Outcome measures
| Measure |
Saizen® E-Device
n=20 Participants
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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|---|---|
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Usefulness and Reliability of E-Device Functions
Display of remaining dose in cartridge: Not Useful
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0 subjects
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Usefulness and Reliability of E-Device Functions
Display of remaining dose in cartridge: Useful
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8 subjects
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Usefulness and Reliability of E-Device Functions
Display of remaining dose in cartridge:Very Useful
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12 subjects
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Usefulness and Reliability of E-Device Functions
Display of last injection date/time: Not Useful
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3 subjects
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Usefulness and Reliability of E-Device Functions
Display of last injection date/time: Useful
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11 subjects
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Usefulness and Reliability of E-Device Functions
Display of last injection date/time: Very Useful
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6 subjects
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Usefulness and Reliability of E-Device Functions
Automatic needle attachment: Not Useful
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0 subjects
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Usefulness and Reliability of E-Device Functions
Automatic needle attachment: Useful
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9 subjects
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Usefulness and Reliability of E-Device Functions
Automatic needle attachment: Very Useful
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11 subjects
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Usefulness and Reliability of E-Device Functions
Audible and visual signals: Not Useful
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1 subjects
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Usefulness and Reliability of E-Device Functions
Audible and visual signals: Useful
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9 subjects
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Usefulness and Reliability of E-Device Functions
Audible and visual signals: Very Useful
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10 subjects
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Usefulness and Reliability of E-Device Functions
Dose injected confirmation: Not Useful
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2 subjects
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Usefulness and Reliability of E-Device Functions
Dose injected confirmation: Useful
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10 subjects
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Usefulness and Reliability of E-Device Functions
Dose injected confirmation: Very Useful
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8 subjects
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Usefulness and Reliability of E-Device Functions
Dose history: Not Useful
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5 subjects
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Usefulness and Reliability of E-Device Functions
Dose history: Useful
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10 subjects
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Usefulness and Reliability of E-Device Functions
Dose history: Very Useful
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5 subjects
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Usefulness and Reliability of E-Device Functions
Customizable needle insertion speed: Not Useful
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2 subjects
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Usefulness and Reliability of E-Device Functions
Customizable needle insertion speed: Useful
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9 subjects
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Usefulness and Reliability of E-Device Functions
Customizable needle insertion speed: Very Useful
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9 subjects
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Usefulness and Reliability of E-Device Functions
Customizable drug insertion speed: Not Useful
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1 subjects
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Usefulness and Reliability of E-Device Functions
Customizable drug insertion speed: Useful
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11 subjects
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Usefulness and Reliability of E-Device Functions
Customizable drug insertion speed: Very Useful
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8 subjects
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Usefulness and Reliability of E-Device Functions
Customizable insertion depth: Not Useful
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1 subjects
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Usefulness and Reliability of E-Device Functions
Customizable insertion depth: Useful
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9 subjects
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Usefulness and Reliability of E-Device Functions
Customizable insertion depth: Very Useful
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10 subjects
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Usefulness and Reliability of E-Device Functions
Teach me menu: Not Useful
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8 subjects
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Usefulness and Reliability of E-Device Functions
Teach me menu: Useful
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7 subjects
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Usefulness and Reliability of E-Device Functions
Teach me menu: Very Useful
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5 subjects
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Usefulness and Reliability of E-Device Functions
On screen instructions: Not Useful
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0 subjects
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Usefulness and Reliability of E-Device Functions
On screen instructions: Useful
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6 subjects
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Usefulness and Reliability of E-Device Functions
On screen instructions: Very Useful
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14 subjects
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Usefulness and Reliability of E-Device Functions
Customizable name and picture: Not Useful
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13 subjects
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Usefulness and Reliability of E-Device Functions
Customizable name and picture: Useful
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7 subjects
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Usefulness and Reliability of E-Device Functions
Customizable name and picture: Very Useful
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0 subjects
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Usefulness and Reliability of E-Device Functions
Pre-programmed dose: Not Useful
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0 subjects
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Usefulness and Reliability of E-Device Functions
Pre-programmed dose: Useful
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6 subjects
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Usefulness and Reliability of E-Device Functions
Pre-programmed dose: Very Useful
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14 subjects
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Usefulness and Reliability of E-Device Functions
Skin sensor: Not Useful
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2 subjects
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Usefulness and Reliability of E-Device Functions
Skin sensor: Useful
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8 subjects
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Usefulness and Reliability of E-Device Functions
Skin sensor: Very Useful
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10 subjects
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SECONDARY outcome
Timeframe: Inclusion visit (Day 1)Population: All subjects who were administered with at least 1 dose of study medication with E-Device.
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.
Outcome measures
| Measure |
Saizen® E-Device
n=20 Participants
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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|---|---|
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Cartridge loading: Difficult
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1 subjects
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Cartridge loading: Easy
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17 subjects
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Cartridge loading: Very Easy
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2 subjects
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Needle attachment: Difficult
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2 subjects
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Needle attachment: Easy
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15 subjects
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Needle attachment: Very Easy
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3 subjects
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Needle detachment: Difficult
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7 subjects
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Needle detachment: Easy
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12 subjects
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Needle detachment: Very Easy
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1 subjects
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Injection process: Difficult
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1 subjects
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Injection process: Easy
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16 subjects
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Injection process: Very Easy
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1 subjects
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Injection process: Missing data
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2 subjects
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Navigation in the menu: Difficult
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2 subjects
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Navigation in the menu: Easy
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17 subjects
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Navigation in the menu: Very Easy
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1 subjects
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Handling of the device: Difficult
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1 subjects
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Handling of the device: Easy
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15 subjects
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Handling of the device: Very Easy
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0 subjects
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Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Handling of the device: Missing data
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4 subjects
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SECONDARY outcome
Timeframe: Inclusion visit (Day 1)Population: All included subjects were analyzed who used at least 1 dose of study medication with E-Device.
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.
Outcome measures
| Measure |
Saizen® E-Device
n=20 Participants
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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|---|---|
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Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit
Dose programming: Missing data
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1 subjects
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Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit
Device setting up: Difficult
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1 subjects
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Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit
Device setting up: Easy
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19 subjects
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Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit
Device setting up: Very Easy
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0 subjects
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Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit
Dose programming: Difficult
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0 subjects
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Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit
Dose programming: Easy
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19 subjects
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Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit
Dose programming: Very Easy
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0 subjects
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SECONDARY outcome
Timeframe: Day 1 up to Day 90Population: All subjects who were administered with at least 1 dose of study medication with E-Device.
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.
Outcome measures
| Measure |
Saizen® E-Device
n=20 Participants
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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|---|---|
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Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs)
AEs
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0 subjects
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Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs)
SAEs
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0 subjects
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Adverse Events
Saizen® E-Device
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Merck KGaA Communication Center
Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER