An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG

NCT00250250 | Completed Phase 3

• 1 other identifier: FE999905 CS002
• Study Type: interventional
• Target: 27
• Locations: 3 countries
• Sites: 6

Brief Summary

Children with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner's syndrome are individually dosed and treated for 12 weeks

Conditions

Turner's Syndrome

Outcome Measures

Primary Outcomes (1)

• To assess the local tolerability of an individualised dose of ZOMACTON 10 mg administered by ZomaJet Vision X

Interventions

ZOMACTON DRUG

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Subjects between the ages of 3 and 17 years (both inclusive) with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner's syndrome. Subjects have for a minimum of 6 months prior to study enrolment been receiving growth hormone therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (6)

Faculty Hospital Olomouc, Children's Clinic, Endocrinology Outpatient Department, I.P.Pavlova str. 6,

Olomouc, 775 20, Czechia

Location

Faculty Hospital Kralovske Vinohrady, Children's Clinic, Vinohradska str. 159

Prague, 100 81, Czechia

Location

Masaryk Hospital Usti nad Labem, Children's Clinic, Building D2, Endocrinology Outpatient Department, Socialni pece 12a

Ústí nad Labem, 401 13, Czechia

Location

Centre d'Endocrinologie Pediatrique, 25 rue Boudet

Bordeaux, 33000, France

Location

Service de Pédiatrie, Groupe Hospitalier du Havre, 55 bis, rue Gustave Flaubert

Le Havre, 76083, France

Location

Vu medisch centrum, Paediatrics, De Boelelaan 1117, PO Box 7057

Amsterdam, 10007 MB, Netherlands

Location

MeSH Terms

Conditions

Turner Syndrome

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sex Chromosome Disorders; Chromosome Disorders; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 7, 2005
• First Posted: November 8, 2005
• Study Start: October 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: August 1, 2006
• Last Updated: May 20, 2011

Record last verified: 2011-05

Locations

CZ (3); FR (2); NL (1)