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Dwarfism, Pituitary clinical trials

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NCT ID: NCT01034735 Completed - Clinical trials for Growth Hormone Deficiency

r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial

Start date: July 2008
Phase: Phase 1
Study type: Interventional

The primary objective of the trial was to assess the bioequivalence for two concentrations (5.83 mg/mL and 8 mg/mL) of the new r-hGH liquid multidose formulation using the r hGH freeze-dried multidose formulation (Saizen® 8 mg, 8.8 mg/1.51 mL) as reference. Each volunteer received three r hGH treatments, with each treatment being administered as a single subcutaneous dose of 4 mg r-hGH in a randomized sequence with at least one week of wash-out period between successive treatments.

NCT ID: NCT01009905 Completed - Clinical trials for Growth Hormone Disorder

An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone)

ANSWER
Start date: June 24, 2002
Phase: N/A
Study type: Observational

This study is conducted in the United States of America (USA). The aim of this observational study is to collect data concerning the treatment outcomes and safety for children and adults who are prescribed Norditropin®. Specific objectives include: 1) developing models defining the relationship of Norditropin dose to changes in insulin-like growth factor (IGF-I) and treatment outcomes, accounting for independent factors such as age, gender and puberty and 2) determining the relative predictive values of peak growth hormone (GH) and IGF-I levels and other factors before treatment to clinical outcomes.

NCT ID: NCT00990340 Completed - Clinical trials for Growth Hormone Deficiency

Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method

T-jet®
Start date: September 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to obtain psychological response and user preference information on the use of the T jet® device versus the traditional subcutaneous injection administration of Tev Tropin®. This study will compare subject-reported injection anxiety immediately before the administration of each dose of Tev-Tropin® between a needle-syringe injection method and a needle-free injection method (T-jet®)

NCT ID: NCT00970463 Completed - Clinical trials for Growth Hormone Deficiency

Cardiac Function and Morphology Evaluated by Magnetic Resonance Imaging in Growth Hormone Deficiency and Acromegaly

Start date: January 2006
Phase: N/A
Study type: Observational

To test the hypothesis that both lack and excess of growth hormone (GH) is associated with cardiac abnormalities. Cardiac function and morphology will be evaluated by MRI before and after treatment.

NCT ID: NCT00965484 Completed - Clinical trials for Growth Hormone Deficiency

Genotropin Study Assessing Use of Injection Pen

Start date: October 2009
Phase: Phase 3
Study type: Interventional

Assessment of Genotropin patient and caregiver (Dyad) perception of convenience and preference of Genotropin injection pen. Patients already on genotropin will be asked to use a genotropin pen for 2 months. Patient and caregiver will be asked to complete a questionnaire at baseline and 2 months.

NCT ID: NCT00960128 Completed - Clinical trials for Chronic Kidney Disease

Observational Prospective Study on Patients Treated With Norditropin®

Start date: April 1, 2006
Phase: N/A
Study type: Observational

This observational study is conducted globally. The aim of the study is to investigate the effectiveness and safety of real-life treatment with Norditropin®. The study population will consist of children and adults who are on treatment with Norditropin® in accordance with normal clinical practice.

NCT ID: NCT00957671 Completed - Clinical trials for Traumatic Brain Injury

Anterior Pituitary Hormone Replacement in Traumatic Brain Injury

Start date: November 2003
Phase: Phase 4
Study type: Interventional

Fifteen to twenty percent of adults who suffer a traumatic brain injury (TBI) that requires hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by GH stimulation testing. Moreover, abnormalities have also been established for the cortisol and thyroid axis. The hypothesis of this proposal is that hormone replacement in TBI patients with documented abnormalities in the GH, thyroid, or cortisol axis will improve muscle function, body composition, aerobic capacity (GH) and tests of neuropsychologic function (GH, thyroid, cortisol).

NCT ID: NCT00936403 Completed - Clinical trials for Growth Hormone Disorder

A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone

Start date: August 2009
Phase: Phase 2
Study type: Interventional

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of a long-acting growth hormone (NNC126-0083) in growth hormone deficient children.

NCT ID: NCT00934063 Completed - Clinical trials for Adult Growth Hormone Deficiency

An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin®

GET
Start date: July 2009
Phase: N/A
Study type: Observational

This observational study is conducted in Europe. The aim of this observational study is to investigate the changes in a score (GET-score) which includes quality of life, body composition and cholesterol metabolism in patients on growth hormone treatment. The GET score stands for: Growth hormone deficiency and Efficacy of Treatment, and is a quantitative measurement of the efficacy of the treatment with growth hormone in adults.

NCT ID: NCT00931476 Completed - Healthy Clinical Trials

A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin

Start date: April 6, 2000
Phase: Phase 1
Study type: Interventional

This trial was conducted in the United States of America (USA). The aim of this clinical trial was to investigate the pharmacokinetics of somatropin in healthy Japanese and Caucasian subjects, and to identify somatostatin-related adverse events.