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Omnitrope (Somatropin Subcutaneous) - Summary

 



OMNITROPE SUMMARY

OMNITROPE™ somatropin [rDNA origin] for injection is a polypeptide hormone of recombinant DNA origin.

OMNITROPE™ is indicated for:

  • Long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.
  • Long-term replacement therapy in adults with growth hormone deficiency (GHD) of either childhood- or adult- onset etiology. GHD should be confirmed by an appropriate growth hormone stimulation test.

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NEWS HIGHLIGHTS

Published Studies Related to Omnitrope (Somatropin Subcutaneous)

Effect of the inhaled corticosteroid mometasone on small airway patency in patients with asthma. [2009.05]
The inflammation in asthma involves both the large and the small airways. This study was designed to examine whether mometasone delivered from a dry powder inhaler would improve those parameters thought to reflect patency and obstruction of the small airways (diameter <2 mm)... Mometasone delivered by a dry powder inhaler improved asthma control and pulmonary function in tests reflecting both large and small airways.

more studies >>

Clinical Trials Related to Omnitrope (Somatropin Subcutaneous)

Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone Deficiency [Completed]
To evaluate long-term safety of growth hormone replacement in adult patients with growth hormone deficiency

Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-Onset Growth Hormone Deficiency [Completed]
The primary objective is to evaluate the efficacy and safety of two different dose regimens of r-hGH (Saizen®) in subjects with childhood-onset growth hormone deficiency (COGHD) during the transition phase from childhood to adulthood.

Effect of Growth Hormone in Children With Growth Hormone Deficiency [Completed]
This trial was conducted in the United States of America (USA).

The purpose of the trial was to compare the effect of Norditropin® using different dosing regimens in children suspected of growth hormone deficiency.

Growth Hormone Administration and Its Effects on Cardiovascular Risk Factors in Growth Hormone Deficient Women [Completed]
The purpose of the study is to evaluate the effects of growth hormone replacement on women with growth hormone deficiency. Growth hormone deficiency means the body no longer produces growth hormone due to a tumor or some kind of disease of the brain in an area called the pituitary/hypothalamic region. This is the area of the brain where growth hormone is normally produced. We, the researchers at Massachusetts General Hospital, will establish the effects of growth hormone replacement on cardiovascular parameters (laboratory tests, the flexibility of the arteries, changes in heart rate) in women with growth hormone deficiency. Our goal is to see if this therapy:

- has effects on women's cardiovascular risk markers (special blood tests which indicate

how healthy the heart and arteries are)

- has effects on women's types and levels of various substances circulating in their

blood

- in women affects the stiffness of their arteries and heart rate variability in parallel

with changes in cardiovascular risk markers

- has different effects depending on whether women are pre or post menopausal.

Participation in this study is expected to last approximately 12 months.

Growth Hormone to Increase Immune Function in People With HIV [Active, not recruiting]
Growth hormone plays an important role in the development of the immune system. Studies suggest that growth hormone may promote growth of the thymus, a gland responsible for the production of important immune cells called T cells. Since these cells are lost during the course of HIV infection, it is possible that growth hormone treatment could help restore the immune system. This study will determine whether the administration of growth hormone can increase the size and function of the thymus and cause an increase in the number of new T cells in the blood of people infected with HIV.

Study hypothesis: Growth hormone treatment will enhance T cell production in HIV infected adults.

more trials >>

Page last updated: 2009-10-20

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