Saizen® E-Device User Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00450190
Recruitment Status : Completed
First Posted : March 22, 2007
Last Update Posted : February 19, 2014
Information provided by:
Merck KGaA

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: Electronic device; Electronic Auto-Injector of Saizen® Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
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
Study Start Date : February 2006
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Growth Disorders

Primary Outcome Measures :
  1. To evaluate patients' feedback after 2 weeks of E-Device use with a questionnaire (by phone) on qualitative first global impression of the E-Device and on usefulness and reliability of each E-Device function [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. To evaluate patients' feedback on the use of E-Device by using a questionnaire: To evaluate the nurse/physician's feedback after the E-Device set up at the inclusion visit and To assess the safety during the treatment and follow-up period of the study [ Time Frame: Various time points ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00450190

Sponsors and Collaborators
Merck KGaA
Study Director: Dominique Roger, MD Merck Lipha Santé s.a.s., an affiliate of Merck KGaA, Darmstadt, Germany

Additional Information:
Publications of Results:
Responsible Party: Medical Director, Merck Lipha Santé s.a.s., an affiliate of Merck KGaA, Darmstadt, Germany Identifier: NCT00450190     History of Changes
Other Study ID Numbers: 26443
First Posted: March 22, 2007    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by Merck KGaA:
Growth disorders/drug therapy

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes