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Dwarfism, Pituitary clinical trials

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NCT ID: NCT01543880 Completed - Clinical trials for Adult Growth Hormone Deficiency

Safety and Efficacy of Long-term Somatropin Treatment in Adults

NordiWIN
Start date: July 2003
Phase: N/A
Study type: Observational

This study is conducted in Europe. The aim of the study is to evaluate safety and efficacy in adults treated with somatropin (Norditropin®).

NCT ID: NCT01543867 Completed - Turner Syndrome Clinical Trials

Safety and Efficacy of Long-term Somatropin Treatment in Children

GrowthWIN II
Start date: January 2001
Phase: N/A
Study type: Observational

This study is conducted in Europe. The aim of this study is to evaluate safety during the long-term use of somatropin (Norditropin®) in children as well as efficacy on change in height. A subgroup of children small for their gestational age is included.

NCT ID: NCT01514500 Completed - Healthy Clinical Trials

First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

Start date: January 16, 2012
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe. The aim of this trial is to assess safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0195-0092 (somapacitan) compared to placebo in healthy male subjects.

NCT ID: NCT01504802 Completed - Clinical trials for Idiopathic Short Stature

Pharmacodynamics of CNP During Growth Hormone Treatment

Start date: November 2010
Phase: N/A
Study type: Observational

It is now widespread practice to treat children with short stature with growth hormone. However, how an individual child will respond to growth hormone treatment is unpredictable and highly variable. Some children will not respond to growth hormone treatment at all. Currently, the only way to determine how well growth hormone therapy is working is to wait until they have been treated for six months and to compare the pre-treatment growth velocity with the growth velocity on treatment. It would be helpful to have a blood test that could be done shortly after starting growth hormone that could predict whether how well a child is responding to treatment. Such a blood test would allow endocrinologists to adjust the growth hormone dose (or possibly stop it altogether, if it is not working) long before the six months it currently takes. C-type natriuretic peptide (CNP) and its partner amino-terminal propeptide of CNP (NTproCNP) are proteins that play a critical role in regulating growth. The investigators have previously shown that blood levels of these proteins increase in children being treated with growth hormone. The investigators believe that a blood test for these proteins will be useful in predicting a child's response to growth hormone treatment. The purpose of this study is to determine when after starting growth hormone, the blood levels of CNP and NTproCNP start to increase.

NCT ID: NCT01502124 Completed - Clinical trials for Growth Hormone Disorder

Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency

Start date: May 8, 2001
Phase: Phase 3
Study type: Interventional

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety profiles of Norditropin® (lyophilized somatropin) and Norditropin® cartridges (liquid somatropin) in children with growth hormone deficiency.

NCT ID: NCT01500486 Completed - Clinical trials for Growth Hormone Disorder

Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™

Start date: January 2007
Phase: N/A
Study type: Observational

This study is conducted in Europe. The aim of this study is to evaluate ease of injection of growth hormone in patients using Norditropin NordiFlex® with NordiFlex PenMate™. Convenience and tolerability of NordiFlex PenMate™ - an automatic injection and a needle hiding device - is also evaluated.

NCT ID: NCT01495468 Completed - Clinical trials for Growth Hormone Deficiency

Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children

Start date: March 2007
Phase: Phase 3
Study type: Interventional

This was a multicenter, randomized, open-label, parallel controlled phase III study, compared pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration formulation). All the subjects were randomized into two groups, test group (PEG somatorpin) and control group (Jintropin AQ), 200 children were enrolled in test group and 100 children were enrolled in control group. Considering the case loss during the clinical study, 20% of the patients were added in each of the group, that is 240 children were in test group and 120 children were in control group, totally 360 children were enrolled in the phase III clinical study. Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary time point was 3 month and 6 month after treatment, if the treatment was less than 6 months, the evaluation would be made when the treatment is finished.

NCT ID: NCT01467193 Completed - Insulin Sensitivity Clinical Trials

The Effect of Dietary Fat Load and Physical Exercise on the Flexibility and Partitioning of Ectopic Lipids.

Start date: August 2011
Phase:
Study type: Observational

This study aims at assessing the effect of standardized dietary fat load and short-term aerobic exercise on systemic lipolysis, flexibility and partitioning of ectopic fat stores (intramyocellular = IMCL, intrahepatocellular = IHCL, intramyocardial lipids = IMCaL) in relation to FFA in endurance trained athletes and hypopituitary patients compared to sedentary healthy control subjects. Exercise is a powerful stimulation for growth hormone (GH) secretion in health. A standardised exercise test can, therefore, be discriminative for the diagnosis of GH-deficiency in adults. This will be assessed. Hypothesis (ectopic fat stores) 1. Ectopic fats stores are flexible fuel stores and are influenced by diet and physical activity.FFA availability may play an important regulatory role. 2. There is a tissue specific partitioning of triglycerides and/or FFA among non-adipose organs after fat load and physical exercise 3. The flexibility of ectopic fat stores is related to insulin sensitivity 4. Lipolytic and anti-lipolytic hormones are critical for regulating FFA availability (at rest or during exercise) and therefore also for the regulation of ectopic fat stores. 5. GH is a lipolytica hormone. Lack of GH in adulthood is related to decreased FFA availability thereby influencing ectopic lipid stores Hypothesis diagnosis of GHD 6. A short intensive physical exercise shows a good discriminative power to diagnose GHD.

NCT ID: NCT01440686 Completed - Clinical trials for Growth Hormone Deficiency

Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers

HL-032
Start date: September 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of HL-032 after oral administration in healthy male volunteers.

NCT ID: NCT01419249 Completed - Turner Syndrome Clinical Trials

First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study

Start date: September 2011
Phase: Phase 4
Study type: Interventional

PREDICT Validation is a validation pharmacogenetic trial. The purpose of this study is to confirm that some genes can be used to predict how well a subject diagnosed with idiopathic growth hormone deficiency (IGHD) or turner syndrome (TS) will respond to a treatment with recombinant human growth hormone (r-hGH).