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Saizen® E-Device User Trial

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00450190
First received: March 21, 2007
Last updated: August 11, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
Growth Disorders
 Device: Electronic device; Electronic Auto-Injector of Saizen®
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Growth Disorders
Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 20
Study Start Date: February 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450190

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

Additional Information:
Full FDA approved prescribing information can be found here  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Medical Director, Merck Lipha Santé s.a.s., an affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT00450190     History of Changes
Other Study ID Numbers: 26443
Study First Received: March 21, 2007
Last Updated: August 11, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Merck KGaA:
Growth disorders/drug therapy

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on June 13, 2013