Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease
NCT00511329
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1. Referral for continued poor growth (growth velocity less than the 25th percentile)
2. Height less than the 10th percentile
3. Weight less than the 10th percentile compared to age and gender- matched normal values.
1. Previous diagnosis with diabetes, chronic fevers (temp > 101.5) or chronic bacterial
infection
2. Previous treatment with GH
3. Bone age > 17
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Descriptive Information | ||||
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Brief Title ICMJE | Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease | |||
Official Title ICMJE | Growth and the Effect of Genotropin in Chronically Ill Children With Juvenile Rheumatoid Arthritis and With Crohn's Disease | |||
Brief Summary | 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. | |||
Detailed Description |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 Phase 3 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE | Drug: 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. Other Name: Genotropin | |||
Study Arms ICMJE | Experimental: Somatropin
Intervention: Drug: somatropin [rDNA origin] for injection | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 10 | |||
Original Estimated Enrollment ICMJE | 32 | |||
Actual Study Completion Date ICMJE | May 2010 | |||
Actual Primary Completion Date | May 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 5 Years to 17 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00511329 | |||
Other Study ID Numbers ICMJE | GA628132 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Nationwide Children's Hospital | |||
Study Sponsor ICMJE | Nationwide Children's Hospital | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Nationwide Children's Hospital | |||
Verification Date | March 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |