Saizen® E-Device User Trial

NCT00450190 | Completed Phase 3 Results

• 1 other identifier: 26443
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Growth Disorders

Keywords

Growth disorders

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Subjects' Feedback Immediately After Initial Training During Inclusion Visit

  Inclusion visit (Day 1)

• Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit

  Inclusion visit (Day 1)

• Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs)

  Day 1 up to Day 90

Study Arms (1)

Saizen® E-Device

EXPERIMENTAL

Device: Saizen® E-Device

Interventions

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.

Saizen® E-Device

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• Known hypersensitivity to somatropin or any of the excipients
• Epiphyseal fusion
• Active neoplasia (either newly diagnosed or recurrent)
• History of intracranial hypertension with papilledema
• Diabetes mellitus or history of significant glucose intolerance as defined by a fasting blood glucose \> 116 mg/dL
• Severe congenital malformations
• Severe psychomotor retardation
• Known hepatic disease as defined by elevated liver enzymes or total bilirubin (x 2 N)
• Current congestive heart failure, untreated hypertension, serious chronic oedema of any cause
• Chronic infectious disease
• Previous or ongoing treatment with sex steroid therapy such as estrogens and testosterone
• Previous or ongoing treatment with any therapy that may directly influence growth, including GH, GHRF and long duration corticosteroids therapy
• Proliferative or preproliferative diabetic retinopathy
• Evidence of any progression or recurrence of an underlying intra-cranial space occupying lesion
• Precocious puberty

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Related Publications (1)

• 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.

  PMID: 18589398 RESULT

Related Links

• Full FDA approved prescribing information can be found here

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck Lipha Santé s.a.s., an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2007
• First Posted: March 22, 2007
• Study Start: February 28, 2006
• Primary Completion: September 30, 2006
• Study Completion: September 30, 2006
• Last Updated: July 23, 2018
• Results First Posted: July 23, 2018

Record last verified: 2017-09