Saizen® E-Device User Trial

• Sponsor: Merck KGaA, Darmstadt, Germany (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00450190
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Actual Duration (Months): 7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Growth Disorders	Device: Saizen® E-Device	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: User Trial on the Use in Common Practice of a New Electronic Auto-injector of Saizen®, the E-Device (Electronic Device), in Children Treated by Recombinant Human Growth Hormone Over a Period of 2 Months
• Actual Study Start Date: Feb 28, 2006
• Actual Primary Completion Date: Sep 30, 2006
• Actual Study Completion Date: Sep 30, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Saizen® E-Device	Device: Saizen® E-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.

Outcome Measures

Primary Outcome Measures

1. Subjects' Overall Impression After Using E-Device [2 Weeks]

   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. Usefulness and Reliability of E-Device Functions [2 Weeks]

   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.

Secondary Outcome Measures

1. Subjects' Feedback Immediately After Initial Training During Inclusion Visit [Inclusion visit (Day 1)]

   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.

2. Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit [Inclusion visit (Day 1)]

   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.

3. Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) [Day 1 up to Day 90]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

1. Patients naïve to, or experienced with, Saizen® with growth disorders in registered indications (GHD, Turner's Syndrome, Chronic Renal Failure, patient born Small Gestational Age [SGA] according to the local SmPC)

2. Written informed consent must be obtained from the parent(s)/legal guardian(s) at the beginning of the study. Children able to understand the trial should personally sign and date the written informed consent

Exclusion Criteria:

1. Known hypersensitivity to somatropin or any of the excipients

2. Epiphyseal fusion

3. Active neoplasia (either newly diagnosed or recurrent)

4. History of intracranial hypertension with papilledema

5. Diabetes mellitus or history of significant glucose intolerance as defined by a fasting blood glucose > 116 mg/dL

6. Severe congenital malformations

7. Severe psychomotor retardation

8. Known hepatic disease as defined by elevated liver enzymes or total bilirubin (x 2 N)

9. Current congestive heart failure, untreated hypertension, serious chronic oedema of any cause

10. Chronic infectious disease

11. Previous or ongoing treatment with sex steroid therapy such as estrogens and testosterone

12. Previous or ongoing treatment with any therapy that may directly influence growth, including GH, GHRF and long duration corticosteroids therapy

13. Proliferative or preproliferative diabetic retinopathy

14. Evidence of any progression or recurrence of an underlying intra-cranial space occupying lesion

15. Precocious puberty

16. Severe associated pathology affecting growth such as malnutrition, malabsorption or bone dysplasia

17. Concomitant corticoid treatment or levothyroxine treatment other than substitutive treatment, topical or inhaled treatment

18. Participation to any clinical study within the 30 days preceding study entry

19. Pregnancy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merck KGaA, Darmstadt, Germany

Investigators

• Study Director: Medical Responsible, Merck Lipha Santé s.a.s., an affiliate of Merck KGaA, Darmstadt, Germany

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Full FDA approved prescribing information can be found here

Publications

None provided.

• Responsible Party: Merck KGaA, Darmstadt, Germany
• ClinicalTrials.gov Identifier: NCT00450190
• Other Study ID Numbers: 26443
• First Posted: Mar 22, 2007
• Last Update Posted: Jul 23, 2018
• Last Verified: Sep 1, 2017

• Keywords provided by Merck KGaA, Darmstadt, Germany: Growth disorders
• Additional relevant MeSH terms: Growth Disorders

Study Results

Participant Flow

Arm/Group Title	Saizen® E-Device
Arm/Group Description	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.
Period Title: Overall Study
STARTED	20
COMPLETED	18
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Saizen® E-Device
Arm/Group Description	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.
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	11.30 (2.66)
Sex: Female, Male (Count of Participants)
Female	10 50%
Male	10 50%

Outcome Measures

1. Primary Outcome

Title	Subjects' Overall Impression After Using E-Device
Description	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.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

All subjects who were administered with at least 1 dose of study medication with E-Device.

Arm/Group Title	Saizen® E-Device
Arm/Group Description	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.
Measure Participants	20
Bad	0
Good	7
Very Good	13

2. Primary Outcome

Title	Usefulness and Reliability of E-Device Functions
Description	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.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

All subjects who were administered with at least 1 dose of study medication with E-Device.

Arm/Group Title	Saizen® E-Device
Arm/Group Description	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.
Measure Participants	20
Display of remaining dose in cartridge: Not Useful	0
Display of remaining dose in cartridge: Useful	8
Display of remaining dose in cartridge:Very Useful	12
Display of last injection date/time: Not Useful	3
Display of last injection date/time: Useful	11
Display of last injection date/time: Very Useful	6
Automatic needle attachment: Not Useful	0
Automatic needle attachment: Useful	9
Automatic needle attachment: Very Useful	11
Audible and visual signals: Not Useful	1
Audible and visual signals: Useful	9
Audible and visual signals: Very Useful	10
Dose injected confirmation: Not Useful	2
Dose injected confirmation: Useful	10
Dose injected confirmation: Very Useful	8
Dose history: Not Useful	5
Dose history: Useful	10
Dose history: Very Useful	5
Customizable needle insertion speed: Not Useful	2
Customizable needle insertion speed: Useful	9
Customizable needle insertion speed: Very Useful	9
Customizable drug insertion speed: Not Useful	1
Customizable drug insertion speed: Useful	11
Customizable drug insertion speed: Very Useful	8
Customizable insertion depth: Not Useful	1
Customizable insertion depth: Useful	9
Customizable insertion depth: Very Useful	10
Teach me menu: Not Useful	8
Teach me menu: Useful	7
Teach me menu: Very Useful	5
On screen instructions: Not Useful	0
On screen instructions: Useful	6
On screen instructions: Very Useful	14
Customizable name and picture: Not Useful	13
Customizable name and picture: Useful	7
Customizable name and picture: Very Useful	0
Pre-programmed dose: Not Useful	0
Pre-programmed dose: Useful	6
Pre-programmed dose: Very Useful	14
Skin sensor: Not Useful	2
Skin sensor: Useful	8
Skin sensor: Very Useful	10

3. Secondary Outcome

Title	Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Description	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.
Time Frame	Inclusion visit (Day 1)

Outcome Measure Data

Analysis Population Description

All subjects who were administered with at least 1 dose of study medication with E-Device.

Arm/Group Title	Saizen® E-Device
Arm/Group Description	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.
Measure Participants	20
Cartridge loading: Difficult	1
Cartridge loading: Easy	17
Cartridge loading: Very Easy	2
Needle attachment: Difficult	2
Needle attachment: Easy	15
Needle attachment: Very Easy	3
Needle detachment: Difficult	7
Needle detachment: Easy	12
Needle detachment: Very Easy	1
Injection process: Difficult	1
Injection process: Easy	16
Injection process: Very Easy	1
Injection process: Missing data	2
Navigation in the menu: Difficult	2
Navigation in the menu: Easy	17
Navigation in the menu: Very Easy	1
Handling of the device: Difficult	1
Handling of the device: Easy	15
Handling of the device: Very Easy	0
Handling of the device: Missing data	4

4. Secondary Outcome

Title	Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit
Description	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.
Time Frame	Inclusion visit (Day 1)

Outcome Measure Data

Analysis Population Description

All included subjects were analyzed who used at least 1 dose of study medication with E-Device.

Arm/Group Title	Saizen® E-Device
Arm/Group Description	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.
Measure Participants	20
Device setting up: Difficult	1
Device setting up: Easy	19
Device setting up: Very Easy	0
Dose programming: Difficult	0
Dose programming: Easy	19
Dose programming: Very Easy	0
Dose programming: Missing data	1

5. Secondary Outcome

Title	Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description	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.
Time Frame	Day 1 up to Day 90

Outcome Measure Data

Analysis Population Description

All subjects who were administered with at least 1 dose of study medication with E-Device.

Arm/Group Title	Saizen® E-Device
Arm/Group Description	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.
Measure Participants	20
AEs	0
SAEs	0

Adverse Events

Arm/Group Title	Saizen® E-Device
Arm/Group Description	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.
All Cause Mortality
	Saizen® E-Device
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Saizen® E-Device
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Saizen® E-Device
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.