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

Learn more about:
Related Clinical Trial
Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long-Acting Growth Hormone Therapy Impact of GH Measurements on GHD Diagnosis Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™ The Impact of the Use of Recombinant Human Growth Hormone on ADHD Characteristics in Children and Adolescents Constructing an Insulin-Like Growth Factor-based Prediction Model Peripheral Metabolic Effects of Somatostatin Chromosome 18 Clinical Research Center The Effect of Dietary Fat Load and Physical Exercise on the Flexibility and Partitioning of Ectopic Lipids. An Observational Study on Treatment Compliance by Children Treated With Growth Hormone A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese Growth Hormone as Add-on Treatment in Severe Fibromyalgia With Low IGF-1 Serum Levels (56 Characters) A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood Safety and Efficacy of Long-term Somatropin Treatment in Adults Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial Effects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal Muscle Genotropin Study Assessing Use of Injection Pen Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary Validation of a Questionnaire That Identifies the Reasons for Non-adherence to Existing Growth Hormone Therapy Treatment of Children With Insufficient Secretion of Growth Hormone Metabolic and QOL Effects of GH Treatment in Patients With TBI and AGHD Anterior Pituitary Hormone Replacement in Traumatic Brain Injury Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA) Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children Inter-Assay Growth Hormone and IGF-I Variability A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device Cardiovascular Risk in Growth Hormone Deficient Young Adult Males After Completing Growth Hormone Therapy Easypod United States User Trial National Cooperative Growth Study in CKD Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult Patients Practicability and Acceptability of Stylomax® in Children Growth Hormone’s Effect on the Cardiovascular System Exploring Interactions Between Growth Hormone and the Microbiome Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children Phase 1 Safety Study of ALRN-5281 in Healthy Subjects Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients Growth Hormone and Chromosome 18q- and Abnormal Growth An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin® Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects 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 Study of TV-1106 in Growth Hormone-Deficient Adults Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production Rates Gene Expression in Monocytes of Growth Hormone Deficient Children Study of Pituitary Size and Function in Familial Dwarfism of Sindh Adipocyte Function and Somtropin Deficiency Sustained Release Formulation of Somatropin (rDNA Origin)for Injection Molecular Basis of the Growth Axis in Short Stature Cardiac and Skeletal Muscle Energy Metabolism in Abnormal Growth Hormone States The Effects of Growth Hormone (GH) on Lipid Depots The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients Reference Values for Body Composition Parameters and IGF-I in the Adult NordiNet® International Outcome Study Effects of Growth Hormone Supplementation to Adults With Growth Hormone Deficient on Metabolism and Adipose Tissue Molecular Phenotype Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing Metabolic Endocrinology and Growth Hormone in Adults Growth Hormone Treatment of Young Growth Hormone-Deficient Adults Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.) rhGH Therapy on Hepatic Drug Metabolism Skeletal Muscle Effects of GH in Boys Assessment of Cardiovascular Risk Markers in Growth Hormone Deficient Patients With Nonsecreting Pituitary Adenomas Adipose Tissue and Serum Inflammation in GH Deficiency Adipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH Therapy

Brief Title

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

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.

Brief 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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Change from baseline of the % of fat mass assessed by DEXA after 1 year of treatment.


Condition

Growth Hormone Deficiency

Intervention

Blood sample


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

90

Start Date

April 2002

Completion Date

April 2005


Eligibility Criteria

        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
      

Gender

All

Ages

15 Years - 20 Years

Accepts Healthy Volunteers

No

Contacts

Pfizer CT.gov Call Center, , 



Administrative Informations


NCT ID

NCT00156143

Organization ID

307-MET-9002-016

Secondary IDs

A6281018


Study Sponsor

Pfizer


Study Sponsor

Pfizer CT.gov Call Center, Study Director, Pfizer


Verification Date

July 2007