NEWS HIGHLIGHTS
Published Studies Related to Omnitrope (Somatropin Subcutaneous)
Bioequivalence studies of omnitrope, the first biosimilar/rhGH follow-on protein: two comparative phase 1 randomized studies and population pharmacokinetic analysis. [2010.11]
This article discusses the bioequivalence of Omnitrope (Sandoz's rhGH biosimilar) and Genotropin (reference rhGH product), assessed in the first 2 clinical phase 1 studies conducted during the development of Omnitrope. Both of these phase 1 studies were randomized, double-blind, crossover studies, each involving 24 healthy volunteers who underwent pituitary somatrope cell down-regulation using octreotide...
Cost-effectiveness of somatropin for the treatment of short children born small for gestational age. [2010.06]
BACKGROUND: Short children born small for gestational age (SGA) may be at increased risk for long-term morbidity and reduced health-related quality of life (HRQoL) due to their short stature. Normalization of height in childhood and adolescence is possible in such children via the use of the recombinant human growth hormone somatropin. OBJECTIVE: The aim of this study was to determine whether somatropin was a cost-effective treatment option in short children born SGA... CONCLUSION: In this model, somatropin was a cost-effective treatment option for short children born SGA from the perspective of the UK NHS.
Bioequivalence between novel ready-to-use liquid formulations of the recombinant human GH Omnitrope and the original lyophilized formulations for reconstitution of Omnitrope and Genotropin. [2010.06]
OBJECTIVE: Two strengths of a novel ready-to-use liquid preparation of the recombinant human GH (rhGH) Omnitrope were developed to increase the convenience for the patients. DESIGN: Omnitrope 3.3 mg/ml solution or Omnitrope 6.7 mg/ml solution was compared to Omnitrope 5 mg/ml powder and Genotropin 5 mg/ml powder in terms of pharmacokinetics, pharmacodynamics, safety, and local tolerance after a single s.c. dose of 5 mg... CONCLUSIONS: Omnitrope 3.3 mg/ml solution, 6.7 mg/ml solution, and 5 mg/ml powder, and Genotropin 5 mg/ml powder are bioequivalent, have similar pharmacokinetic and pharmacodynamic profiles, and are equally safe. Overall, the products can be considered to be therapeutically interchangeable.
Relative bioavailability of two drug products of somatropin obtained from either the milk of transgenic cows or bacterial culture. [2010]
BACKGROUND: Our objective was to assess the relative bioavailability of the first somatropin produced in transgenic cloned cows that carry the human growth hormone (GH) gene (Biohormon) and somatropin produced in Escherichia coli culture (HHT), the procedure most frequently used for the commercial production of the hormone... CONCLUSION: This study demonstrates that a single dose of Biohormon, the first product with somatropin obtained from milk of transgenic mammals, is bioequivalent to the reference product HHT according to standard criteria. Copyright (c) 2010 S. Karger AG, Basel.
Cost-effectiveness of somatropin for the treatment of short children born small
for gestational age. [2010]
cost-effective treatment option in short children born SGA... CONCLUSION: In this model, somatropin was a cost-effective treatment option for
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.Clickâ„¢ 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.
American Norditropin Studies - Registry of Growth Hormone (GH) Patients [Recruiting]
The Norditropin National Registry is a post-marketing registry of patients using Norditropin
therapy.
A large body of data will be generated to meet the following Registry Objectives:
- To develop a pharmacodynamic model defining the relationship of Norditropin dose to IGF
changes, accounting for effects of known or suspected independent variables such as
age, gender and puberty
- To develop a model defining the relationship of GH dose and IGF exposure to treatment
outcomes, accounting for effects of known or suspected independent variables such as
age, gender and puberty
- To develop a safety model that related GH doses to adverse even occurrence, again
accounting for the effects of known or suspected independent variables
- To determine the relative predictive values of pre-treatment GH stimulation tests and
pre-treatment IGF-I and IGFBP-3 levels
Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects [Recruiting]
Convenience and preference for the new Mark VII pen compared to the current Genotropin pen
will be assessed using a questionaire. it is expected that the new pen will be preferred or
at least no different to the current pen.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Pegylated-Somatropin in Healthy Volunteers [Recruiting]
Reports of Suspected Omnitrope (Somatropin Subcutaneous) Side Effects
Headache (4),
Viith Nerve Paralysis (3),
Rash (2),
Convulsion (2),
Syncope (2),
Hypersensitivity (1),
Haemorrhage (1),
Eczema (1),
Pyrexia (1),
Drug Abuse (1), more >>
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