Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
EMD Serono |
---|---|
Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00256126 |
The study aims at identifying the predictive markers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome children. The study will recruit approximately 360 children in several countries worldwide. The study lasts for about the first one month of daily growth hormone treatment. There will be three clinic visits during the month of the study. There is an initial visit, then a visit before growth hormone treatment starts and finally a visit at the fourth week of treatment. The study requires two additional blood tests to a regular Saizen treatment follow-up. One sample is taken before growth hormone injections start and one additional blood sample is taken at the fourth week of treatment.
Condition | Intervention | Phase |
---|---|---|
Growth Hormone Deficiency |
Drug: Saizen |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase IV Open-Label Study of Predictive Markers in Growth Hormone Deficient and Turner Syndrome Pre-Pubertal Children Treated With SAIZEN® |
Enrollment: | 318 |
Study Start Date: | May 2005 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Saizen
blood sampling (10 ml) at baseline and one month (10 ml)
|
Ages Eligible for Study: | 2 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A)GHD: documented pre-established diagnosis of GHD with a GH peak response of <10 μg/L with 2 GH stimulation tests, without priming with oestradiol. B)Turner syndrome: documented pre-established diagnosis by karyotype.
Exclusion Criteria:
Argentina | |
Local Medical Information Office | |
Buenos Aires, Argentina | |
Australia | |
Local Medical Information Office | |
Sydney, Australia | |
Austria | |
Local Medical Information Office | |
Vienna, Austria | |
Canada | |
Local Medical Information Office | |
Mississauga, Canada | |
France | |
Local Medical InformationOffice | |
Paris, France | |
Germany | |
Local Medical Information Office | |
Munich, Germany | |
Italy | |
Local Medical Information Office | |
Rome, Italy | |
Norway | |
Local Medical Information Office | |
Oslo, Norway | |
Russian Federation | |
Local Medical Information Office | |
Russia, Russian Federation | |
Singapore | |
Local Medical Information Office | |
Singapore, Singapore | |
Spain | |
Local Medical Information Office | |
Madrid, Spain | |
Sweden | |
Local Medical Information Office | |
Stockholm, Sweden | |
United Kingdom | |
Local Medical Information Office | |
Feltham, United Kingdom |
Study Chair: | Clement Olivier | Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany |
Responsible Party: | Merck Serono International SA, an affiliate of Merck KGaA Darmstadt, Germany ( Clement Olivier ) |
Study ID Numbers: | 24531 |
Study First Received: | November 18, 2005 |
Last Updated: | March 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00256126 History of Changes |
Health Authority: | United Kingdom: National Health Service |
Dwarfism Bone Diseases, Endocrine Hypothalamic Diseases Hypopituitary Dwarfism Pituitary Diseases Genital Dwarfism Central Nervous System Diseases Endocrine System Diseases Dwarfism, Pituitary Ovarian Dwarfism |
Brain Diseases Hormones Bone Diseases Monosomy X Turner Syndrome Growth Hormone Deficiency Musculoskeletal Diseases Hypopituitarism Bone Diseases, Developmental Endocrinopathy |
Dwarfism Bone Diseases, Endocrine Hypothalamic Diseases Pituitary Diseases Nervous System Diseases Central Nervous System Diseases Endocrine System Diseases |
Dwarfism, Pituitary Brain Diseases Bone Diseases Musculoskeletal Diseases Hypopituitarism Bone Diseases, Developmental |