CLINICAL TRIALS PROFILE FOR HUMATROPE
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All Clinical Trials for HUMATROPE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00001305 ↗ | Growth Hormone Therapy in Osteogenesis Imperfecta | Completed | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 3 | 1991-11-05 | Growth deficiency is a key feature of severe Osteogenesis Imperfecta (OI) and a frequent feature of mild to moderate forms of the disease. The reason that children with OI are short is not fully understood. We do know that details such as the number of fractures suffered or the type of OI do not fully explain the short stature of OI. Growth patterns have been defined for children with OI Types I, III, and IV. At about 12 months of age, children with Types III and IV OI demonstrate a predictable plateau of their linear growth rate. Type IV OI children begin to resume a normal growth rate at about age four to five years, but they will not "catch up" to a normal height, as they have "lost" a significant period of growth. The plateau usually continues for children with Type III OI. The reason for this growth plateau is unknown. There have been no studies which evaluate the growth of OI children in this age range. Our previous studies of growth in OI children have begun at age 5 years. We have studied growth in OI children for the past 10 years. Different medications have been tried to both stimulate growth and improve bone density. Some children have responded to growth hormone (their growth rate increased by at least 50%) and some did not. The majority of children who did respond were Type IV. However, we need to carefully treat and study more children to try to determine which children will benefit from growth hormone medication. The Goals of this Study Are: 1. We want to try to find a cause for the growth plateau common in types III and IV OI. Long-term, our goal is to develop a treatment to eliminate this plateau. 2. We want to see how long and how well OI bone will respond to growth stimulation. 3. We hope to find a "predictor" for who will respond to growth hormone and who will not, by measuring your child's endocrine and growth hormone function before receiving any growth hormone treatment. 4. We want to measure the effects of growth stimulation on bone density, and the quality of OI bone. 5. We want to see if there are long term benefits resulting from this treatment in the form of final adult height, trunk height, and possibly improved function of the respiratory system. Median Subject Age (on p. 1 of webpage): 1-15 years (replaces 0-20) |
| NCT00001343 ↗ | The Effects of Hormones in Growth Hormone-Treated Girls With Turner Syndrome | Completed | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 2 | 1992-12-11 | Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Patients with Turner syndrome are typically short, have abnormal physical features, and lack the physical changes normally associated with puberty. In addition, some patients with Turner syndrome have low bone density (osteoporosis) and differences in learning abilities. This study will research the effects of steroid hormones on patients with Turner syndrome. It will look closely at how taking steroid hormones effects the patient's rate of growth as well as the patient's ability to learn. In addition the study will investigate how different hormones (androgen and estrogen) work when given together as a combination. All patients asked to participate in this study will receive growth hormone injections. However, half of the patients will receive an additional sex steroid hormone (oxandrolone) in the form of a pill. The other half of the patients will receive a placebo or "sugar pill". This will allow the researchers to determine if the combination of the hormones produces different results than growth hormone alone. The study will last approximately 2 years. After 2 years of research the patients may qualify for an additional 2 years of treatment. Patients may benefit directly from this research with increased growth and improved ability to learn. |
| NCT00190658 ↗ | Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome | Completed | Eli Lilly and Company | Phase 3 | 2000-02-01 | This clinical trial will compare the mean first year height velocity of somatropin-treated prepubertal patients with SHOX deficiency with the height velocity of a control group of untreated prepubertal patients with SHOX deficiency. Both groups will be compared to a somatropin-treated group of girls with Turner syndrome. After the second year patients in the control group have the option to receive treatment as well. All patients will optionally be treated until they achieved adult height. |
| NCT00191074 ↗ | Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature | Completed | Eli Lilly and Company | Phase 3 | 2001-02-01 | After approval of amendment (g), patients who were still receiving study drug at the time were scheduled for a study visit. In addition, patients who had discontinued early from the core, blinded phase of the study were contacted. All of these patients were offered the opportunity to enter the unblinded extension phase (if they met eligibility criteria) and continue somatropin treatment (regardless of initial treatment randomization) until they reached final height. |
| NCT00191113 ↗ | Somatropin Treatment to Final Height in Turner Syndrome | Completed | Eli Lilly and Company | Phase 3 | 1989-02-01 | A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin) treatment in promoting linear growth to final height. |
| NCT00191165 ↗ | Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone Deficiency | Completed | Eli Lilly and Company | Phase 3 | 2004-03-01 | Multi-center, randomized, controlled, open-label, phase III study comparing the effects of two different dosages of somatropin treatment (in-label or doubled) after 12 and 24 months of treatment, on height velocity in early pubertal children with growth hormone deficiency (GHD). The study will be conducted in Italy. Approximately 26 subjects will participate in this study, distributed as 13 in the in-label dosage group (group A) and 13 in the doubled dosage group (group B). |
| NCT00206375 ↗ | Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism | Terminated | Eli Lilly and Company | Phase 4 | 2003-05-01 | The purpose of this study is to see if giving growth hormone and Lupron along with thyroid hormone will improve final height in patients with long term hypothyroidism. Lupron is a medicine which is used to delay puberty and to prevent early closure of growing bones which might increase growth potential. Growth hormone is used to restore growth rate. This study will include children with "short term" and "long term" hypothyroidism. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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