Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00174278

Purpose

To assess the effect of long-term treatment by Genotonorm on linear growth

Condition	Intervention	Phase
Growth Hormone Deficiency Growth Retardation	Drug: Somatropin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treatment With Recombinant Human Growth Hormone (Genotonorm®) In Children With Short Stature Secondary To A Long Term Corticoid Therapy. A Study of Efficacy and Safety.

Resource links provided by NLM:

Genetics Home Reference related topics: combined pituitary hormone deficiency pseudoachondroplasia

MedlinePlus related topics: Dwarfism

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

The main efficacy variable is the height SDS (SEMPE) before and after treatment.
The standing height of the patients is measured during the inclusion visit and at each follow-up visit.
The height measurements are always performed at the same time of the day by
use of a wallmounted device (e.g. Harpenden Stadiometer).
Each child has to be measured three times, the mean of these measurements is recorded in the Case Report Form as the present height.
The body weight is measured by use of a balance scale.
Puberty stage is assessed (according to Tanner´s cotation) at the same visits as height is measured.

Estimated Enrollment:	14
Study Start Date:	February 1997
Study Completion Date:	October 2006

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All the patients who have benefit during one year of a treatment by Genotonorm during the study 94-8123-014
All patients who have stopped during one year will be included if a signed written informed consent

Exclusion Criteria:

Endocrine disease, except well substituted hypothyroidism
Other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174278

Locations

France
Pfizer Investigational Site
Paris, France

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00174278 History of Changes
Other Study ID Numbers:	96-8123-018, A6281217
Study First Received:	September 9, 2005
Last Updated:	August 4, 2008
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Dwarfism
Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn

Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012