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Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device (ZOMAJET)

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.
 
ClinicalTrials.gov Identifier: NCT01306357
Recruitment Status : Completed
First Posted : March 1, 2011
Last Update Posted : February 7, 2012
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Tracking Information
First Submitted Date February 28, 2011
First Posted Date March 1, 2011
Last Update Posted Date February 7, 2012
Study Start Date September 2007
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 28, 2011)
Overall treatment compliance [ Time Frame: up to three years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 28, 2011)
  • Description of the auxological and biochemical characteristics of the population at inclusion (notably the exploration of GH deficiency, the height, the difference in height from the average in SD, the rate of growth prior to treatment) [ Time Frame: Baseline (day 0) ]
  • Description of the Dosages of Growth Hormone and way of use of needle-free device [ Time Frame: up to 3 years ]
  • Description of the evolution of the auxological and biochemical parameters (gain in height in SD, growth rate, IGF-1 if available) [ Time Frame: Baseline (Day 0), up to three years ]
  • Average Duration of Treatment [ Time Frame: up to three years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device
Official Title Evaluation De L'Observance Globale Et De La Duree De Traitement Par Zomacton® Avec Le Stylo Transjecteur Zomajet® Etude Pharmaco-Epidemiologique Observationnelle Longitudinale Prospective
Brief Summary

The purpose of this strictly observational, prospective, longitudinal study is to evaluate with sufficient precision the rate of overall treatment compliance from one year to 3 years of follow-up of the patients.

Somatotropin is indicated in the long-term treatment of children with growth retardation related to a deficiency in secretion of growth hormone and in the long-term treatment of growth retardation related to Turner's syndrome confirmed by chromosomal analysis. These are the two indications of Zomacton® 4 mg and 10 mg injection solution.

The use of the Zomajet® needle-free device (Zomajet® 2 Vision, reserved for the administration of Zomacton® 4 mg or of the Zomajet® Vision X needle-free device, reserved for the administration of Zomacton® 10 mg), allows the product to be administered by percutaneous transjection (needle-free) and can be used by the child directly or by the family after an initial training.

In April 2004, the CEPP (Commission for the Evaluation of Products and Services) requested a follow-up of the cohort of patients using the Zomajet® 2 Vision system measuring the compliance and duration of use of the device.

The number of patients initiated on Zomacton treatment using the Zomajet® needle-free device is estimated to 30. Over a period of inclusion of 3 years, we therefore estimate that 90 patients will be treated. In the cohort studied the patients will be followed-up for 1 year at least and for 3 years at the maximum.

The rate of treatment compliance will be evaluated according to the ratio of the actual duration of administration over the total duration recommended by the physician during the observation period.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients who meet the criteria of the Treatment Information Sheet (growth hormone deficiency or Turner's syndrome) for which treatment is initiated with Zomacton® 4 mg using the Zomajet® 2 Vision needle-free device or with Zomacton® 10 mg using the Zomajet® Vision X.
Condition
  • Turner's Syndrome
  • Human Growth Hormone Deficiency
Intervention Drug: Somatropin
4 mg or 10 mg delivered by needle-free device
Other Names:
  • human growth hormone
  • Zomacton
Study Groups/Cohorts Zomacton® with Zomajet® needle-free device
Zomacton® 4 mg delivered by percutaneous transjection (needle-free) using the Zomajet® 2 Vision device or Zomacton® 10 mg delivered by percutaneous transjection (needle-free) using the Zomajet® Vision X needle-free device.
Intervention: Drug: Somatropin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 31, 2011)
87
Original Actual Enrollment
 (submitted: February 28, 2011)
77
Actual Study Completion Date November 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Growth hormone deficiency
  • Turner's syndrome

Exclusion Criteria:

  • Patients who do not meet the criteria in the treatment Information Sheet
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01306357
Other Study ID Numbers RZO 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Ferring Pharmaceuticals
Original Responsible Party Clinical Development Support, Ferring Pharmaceuticals
Current Study Sponsor Ferring Pharmaceuticals
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
PRS Account Ferring Pharmaceuticals
Verification Date February 2012