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PI left the institution
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The investigators hypothesize that the anabolic effects of Genotropin (somatropin) will improve the height and weight of children with inflammatory based chronic illness who have failed to grow despite receiving adequate nutrition. The investigators will test the hypothesis by treating 32 chronically ill children (16 JRA and 16 Crohn's) with growth hormone (GH) for 12 months and comparing them to baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somatropin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somatropin [rDNA origin] for injection | Drug | Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages. |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome Variables Will be Height and Weight Z Score. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome Variables Will Include Change in Lean Body Mass, Change in Bone Mineral Content, Change in Inflammatory Mediated Cytokine Levels and Change in Bone Turnover. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dana S Hardin, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbus Children's Hospital | Columbus | Ohio | 43205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11739431 | Background | Bechtold S, Ripperger P, Muhlbayer D, Truckenbrodt H, Hafner R, Butenandt O, Schwarz HP. GH therapy in juvenile chronic arthritis: results of a two-year controlled study on growth and bone. J Clin Endocrinol Metab. 2001 Dec;86(12):5737-44. doi: 10.1210/jcem.86.12.8083. | |
| 11782884 | Background | Mauras N, George D, Evans J, Milov D, Abrams S, Rini A, Welch S, Haymond MW. Growth hormone has anabolic effects in glucocorticosteroid-dependent children with inflammatory bowel disease: a pilot study. Metabolism. 2002 Jan;51(1):127-35. doi: 10.1053/meta.2002.28972. |
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PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Somatropin | somatropin [rDNA origin] for injection: Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Somatropin | somatropin [rDNA origin] for injection: Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Outcome Variables Will be Height and Weight Z Score. | PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed. | Posted | 12 months |
|
|
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PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Somatropin | somatropin [rDNA origin] for injection: Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Rice, RN | Nationwide Children's Hospital | 6143553142 | julie.rice@nationwidechildrens.org |
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| D003424 | Crohn Disease |
| D004392 | Dwarfism |
| D005183 | Failure to Thrive |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| D000074584 | WW Domain-Containing Oxidoreductase |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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|
|
| 11549686 | Background | Hardin DS, Ellis KJ, Dyson M, Rice J, McConnell R, Seilheimer DK. Growth hormone decreases protein catabolism in children with cystic fibrosis. J Clin Endocrinol Metab. 2001 Sep;86(9):4424-8. doi: 10.1210/jcem.86.9.7822. |
| 16117811 | Background | Hardin DS, Rice J, Doyle ME, Pavia A. Growth hormone improves protein catabolism and growth in prepubertal children with HIV infection. Clin Endocrinol (Oxf). 2005 Sep;63(3):259-62. doi: 10.1111/j.1365-2265.2005.02331.x. |
| 17018651 | Background | Hardin DS, Adams-Huet B, Brown D, Chatfield B, Dyson M, Ferkol T, Howenstine M, Prestidge C, Royce F, Rice J, Seilheimer DK, Steelman J, Shepherds R. Growth hormone treatment improves growth and clinical status in prepubertal children with cystic fibrosis: results of a multicenter randomized controlled trial. J Clin Endocrinol Metab. 2006 Dec;91(12):4925-9. doi: 10.1210/jc.2006-1101. Epub 2006 Oct 3. |
|
| Age, Continuous | years |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
|
| Secondary | Secondary Outcome Variables Will Include Change in Lean Body Mass, Change in Bone Mineral Content, Change in Inflammatory Mediated Cytokine Levels and Change in Bone Turnover. | PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed. | Posted | 12 months |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000074583 | Short Chain Dehydrogenase-Reductases |
| D064430 | NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases |
| D000429 | Alcohol Oxidoreductases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D025521 | Tumor Suppressor Proteins |
| D009363 | Neoplasm Proteins |
| D011506 | Proteins |