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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR NORDITROPIN

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Clinical Trials for Norditropin

Trial ID Title Status Sponsor Phase Summary
NCT00102817 Somatropin (Norditropin) in Insulin-like Growth Factor (IGF) Deficient Children Completed Novo Nordisk A/S Phase 3 This trial is conducted in the United States of America (USA). This is a 12 month study to determine if Norditropin is safe and effective in children with IGF deficiency.
NCT00184652 Growth Hormone Treatment in Adult Patients With Chronic Kidney Disease Completed Novo Nordisk A/S Phase 2 This trial is conducted in Asia, Europe, and Middle East. Adult patients with chronic kidney disease are treated with growth hormone to assess effect on nutritional status.
NCT00184678 Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency Completed Novo Nordisk A/S Phase 3 This trial is conducted in Europe. Growth Hormone in young adults with growth hormone deficiency in childhood. This trial compares a treated group of patients with an untreated group of patients.
NCT00209235 Albright Hereditary Osteodystrophy: Growth Hormone Trial and Cognitive/Behavioral Assessments Recruiting Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2/Phase 3 We, the researchers, have found that growth hormone deficiency is very common in patients with pseudohypoparathyroidism type 1a, which falls under the broader condition termed Albright hereditary osteodystrophy. Patients with pseudohypoparathyroidism type 1a typically are short and obese. Some of these patients are not short during childhood, but due to a combination of factors, they end up short as adults. We are evaluating the effect of growth hormone treatment in those patients with pseudohypoparathyroidism type 1a who are found to be growth hormone deficient. We hypothesize that growth hormone deficiency may contribute to the short stature and obesity found in this condition. We are also evaluating the effect of growth hormone on patients with pseudohypoparathyroidism type 1a who are not growth hormone deficient (i.e., growth hormone sufficient) in those who had been on study drug through R01 FD003409 or who meet the criteria of idiopathic short stature or SGA. We are also evaluating neurocognitive and psychosocial functioning in participants with AHO in order to determine the specific impairments that are most common in the condition and to determine the best approach toward management. Funding source -- Growth hormone study: FDA OOPD [R01 FD003409 (which has ended) and R01 FD002568 (which has ended)] Cognitive/behavior: NICHD R21 HD078864
NCT00209235 Albright Hereditary Osteodystrophy: Growth Hormone Trial and Cognitive/Behavioral Assessments Recruiting Johns Hopkins University Phase 2/Phase 3 We, the researchers, have found that growth hormone deficiency is very common in patients with pseudohypoparathyroidism type 1a, which falls under the broader condition termed Albright hereditary osteodystrophy. Patients with pseudohypoparathyroidism type 1a typically are short and obese. Some of these patients are not short during childhood, but due to a combination of factors, they end up short as adults. We are evaluating the effect of growth hormone treatment in those patients with pseudohypoparathyroidism type 1a who are found to be growth hormone deficient. We hypothesize that growth hormone deficiency may contribute to the short stature and obesity found in this condition. We are also evaluating the effect of growth hormone on patients with pseudohypoparathyroidism type 1a who are not growth hormone deficient (i.e., growth hormone sufficient) in those who had been on study drug through R01 FD003409 or who meet the criteria of idiopathic short stature or SGA. We are also evaluating neurocognitive and psychosocial functioning in participants with AHO in order to determine the specific impairments that are most common in the condition and to determine the best approach toward management. Funding source -- Growth hormone study: FDA OOPD [R01 FD003409 (which has ended) and R01 FD002568 (which has ended)] Cognitive/behavior: NICHD R21 HD078864
NCT00209235 Albright Hereditary Osteodystrophy: Growth Hormone Trial and Cognitive/Behavioral Assessments Recruiting Hugo W. Moser Research Institute at Kennedy Krieger, Inc. Phase 2/Phase 3 We, the researchers, have found that growth hormone deficiency is very common in patients with pseudohypoparathyroidism type 1a, which falls under the broader condition termed Albright hereditary osteodystrophy. Patients with pseudohypoparathyroidism type 1a typically are short and obese. Some of these patients are not short during childhood, but due to a combination of factors, they end up short as adults. We are evaluating the effect of growth hormone treatment in those patients with pseudohypoparathyroidism type 1a who are found to be growth hormone deficient. We hypothesize that growth hormone deficiency may contribute to the short stature and obesity found in this condition. We are also evaluating the effect of growth hormone on patients with pseudohypoparathyroidism type 1a who are not growth hormone deficient (i.e., growth hormone sufficient) in those who had been on study drug through R01 FD003409 or who meet the criteria of idiopathic short stature or SGA. We are also evaluating neurocognitive and psychosocial functioning in participants with AHO in order to determine the specific impairments that are most common in the condition and to determine the best approach toward management. Funding source -- Growth hormone study: FDA OOPD [R01 FD003409 (which has ended) and R01 FD002568 (which has ended)] Cognitive/behavior: NICHD R21 HD078864
NCT00254514 Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone in Tibia Fractures Completed Novo Nordisk A/S Phase 2 This trial is conducted in Africa, Europe and Middle East. This trial investigates the efficacy and safety of three dose levels of Norditropin® (growth hormone) as compared to placebo in the treatment of tibia fractures. The trial will be conducted in two parts: in the first part, the patients will be evaluated with regard to efficacy (fracture healing) and safety at short time intervals until week 24 post-surgery. In the second part, long-term safety and fracture healing up to 12 months post-surgery will be evaluated.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Norditropin

Condition Name

Condition Name for Norditropin
Intervention Trials
Growth Hormone Disorder 25
Genetic Disorder 13
Adult Growth Hormone Deficiency 12
Growth Hormone Deficiency in Children 11
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Condition MeSH

Condition MeSH for Norditropin
Intervention Trials
Dwarfism, Pituitary 25
Endocrine System Diseases 15
Syndrome 9
Turner Syndrome 8
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Clinical Trial Locations for Norditropin

Trials by Country

Trials by Country for Norditropin
Location Trials
United States 83
Germany 11
France 11
Sweden 10
Denmark 9
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Trials by US State

Trials by US State for Norditropin
Location Trials
New York 6
Pennsylvania 5
Ohio 5
California 5
Washington 5
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Clinical Trial Progress for Norditropin

Clinical Trial Phase

Clinical Trial Phase for Norditropin
Clinical Trial Phase Trials
Phase 4 3
Phase 3 12
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Norditropin
Clinical Trial Phase Trials
Completed 36
Enrolling by invitation 3
Recruiting 3
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Clinical Trial Sponsors for Norditropin

Sponsor Name

Sponsor Name for Norditropin
Sponsor Trials
Novo Nordisk A/S 45
Johns Hopkins University 2
Oregon Health and Science University 1
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Sponsor Type

Sponsor Type for Norditropin
Sponsor Trials
Industry 45
Other 14
NIH 1
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