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

• ClinicalTrials.gov Identifier: NCT01306357
• Recruitment Status: Completed
• First Posted: March 1, 2011
• Last Update Posted: February 7, 2012
• Sponsor: Ferring Pharmaceuticals
• 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

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

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

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