Primary outcomeNumber· 2 Weeks
Subjects' Overall Impression After Using E-Device
| Group | Value (subjects) |
|---|---|
| Saizen® E-Device | 0 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataSaizen® E-Device User Trial
NCTNCT00450190 (opens ClinicalTrials.gov in a new tab)Other id26443
This trial does not test a peptide that PepBank tracks.
- Measures HGH (somatotropin), does not give it. It appears in the eligibility rules.
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 20 participants (actual)
- Sponsor
- Merck KGaA, Darmstadt, Germany · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
- Not stated
- Start
- 28 Feb 2006
- Primary completion
- 30 Sept 2006
- Completion
- 30 Sept 2006
- First posted
- 22 Mar 2007 (estimated)
- Last update posted
- 23 Jul 2018
- Conditions
- Growth Disorders
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20062007
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Saizen® E-DeviceDevice
Arms1
Experimental
Saizen® E-Device
Primary outcomes2
Outcomes the sponsor listed as primary.
Subjects' Overall Impression After Using E-Device
Time frame · 2 Weeks
Registry 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.
Usefulness and Reliability of E-Device Functions
Time frame · 2 Weeks
Registry 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.
Secondary outcomes(3)
Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Time frame · Inclusion visit (Day 1)
Registry 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.
Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit
Time frame · Inclusion visit (Day 1)
Registry 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.
Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame · Day 1 up to Day 90
Registry 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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeNumber· 2 Weeks
Usefulness and Reliability of E-Device Functions
| Group | Value (subjects) |
|---|---|
| Saizen® E-Device | 0 |
Secondary and other outcome results(3)
Secondary outcomeNumber· Inclusion visit (Day 1)
Subjects' Feedback Immediately After Initial Training During Inclusion Visit
| Group | Value (subjects) |
|---|---|
| Saizen® E-Device | 1 |
Secondary outcomeNumber· Inclusion visit (Day 1)
Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit
| Group | Value (subjects) |
|---|---|
| Saizen® E-Device | 1 |
Secondary outcomeNumber· Day 1 up to Day 90
Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs)
| Group | Value (subjects) |
|---|---|
| Saizen® E-Device | 0 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Saizen® E-DeviceSaizen® (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. | – | 0 / 20 | 0 / 20 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- ResultTauber 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. PMID 18589398
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- Not stated
- Healthy volunteers
- Not stated
Inclusion and exclusion criteria, as posted
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
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