Clinical Trials Logo
  1. Home
  2. Growth Hormone Deficiency
  3. NCT00156143
  4. Details
NCT00156143 Clinical Trial

Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents

Growth Hormone Deficiency Clinical Trial

— TAUBER  

Official title:
GH Therapy in Partial GHD Adolescents : Evaluation of Efficacy Based on Body Composition and Comparison of 2 Different Doses of Genotonorm®. Open-Label, Randomised, Comparative, Controlled, Parallel-Group, Multi-Center Phase IIIB Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00156143
Other study ID # 307-MET-9002-016
Secondary ID A6281018
Status Completed
Phase Phase 3
First received September 7, 2005
Last updated July 27, 2007
Start date April 2002
Est. completion date April 2005

Study information
Verified date July 2007
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

To evaluate in boys and girls the improvement in body composition under GH treatment in adolescents with CO-GHD who remain partially GHD after GH discontinuation.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 20 Years
Eligibility Inclusion Criteria:

- Males or females : Chronological age > or = 15 years and < or = 20 years for females

- Chronological age > or = 17 years and < or = 20 years for males

- GHD of childhood onset treated for at least 2 years

- Last GH injection at least 12 months before baseline visit

Exclusion Criteria:

- Turner's syndrome

- Chronic hepatic impairment as shown by GGT and / or ASAT and / or ALAT > 2 X ULN

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood sample

• Radiography

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline of the % of fat mass assessed by DEXA after 1 year of treatment.
See also
  Status Clinical Trial Phase
Recruiting NCT02243852 - Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21) N/A
Completed NCT01440686 - Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers Phase 1
Completed NCT00990340 - Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method Phase 4
Completed NCT00149708 - Consequence of Lifetime Isolated Growth Hormone Deficiency N/A
Completed NCT00235599 - The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children. N/A
Completed NCT00459940 - The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients N/A
Completed NCT01157793 - A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood Phase 4
Completed NCT00004365 - Study of Pituitary Size and Function in Familial Dwarfism of Sindh N/A
Recruiting NCT00227253 - Chromosome 18 Clinical Research Center
Recruiting NCT04121780 - Growth Hormone Replacement Therapy for Retried Professional Football Players Phase 2
Completed NCT02934399 - Dynamic Hormone Diagnostics in Endocrine Disease
Completed NCT01090778 - Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I) Phase 2
Completed NCT01062529 - Peripheral Metabolic Effects of Somatostatin N/A
Completed NCT00965484 - Genotropin Study Assessing Use of Injection Pen Phase 3
Completed NCT00616278 - National Cooperative Growth Study in CKD N/A
Completed NCT02693522 - Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency Phase 3
Recruiting NCT02908958 - Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency Phase 4
Terminated NCT01243892 - A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device N/A
Withdrawn NCT00638287 - Inter-Assay Growth Hormone and IGF-I Variability N/A
Completed NCT00929799 - Growth Hormone and Glucose Metabolism Phase 4