A Phase 2/3 interventional study of somatropin [rDNA origin] for injection in Arthritis, Juvenile Rheumatoid and Crohn Disease, sponsored by Nationwide Children's Hospital. Terminated at 1 site in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-04-12.
Sponsored by Nationwide Children's Hospital · Phase 2/3, Interventional, and Treatment
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 10 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Nationwide Children's Hospital is the lead sponsor of 231 studies on the registry; 43 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 8 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: Genotropin
The Primary Outcome Variables Will be Height and Weight Z Score.
Time frame: 12 months
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.
Time frame: 12 months
| Milestone | Somatropin |
|---|---|
| Started | 0 |
| Completed | 0 |
| Not completed | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Somatropin | — | — | — |
PI left institution suddenly in 2010 and studies were closed. Study records for participants cannot be located and possibly have been destroyed.
| Age, Categorical | Somatropin |
|---|---|
| <=18 years | — |
| Between 18 and 65 years | — |
| >=65 years | — |
| Age, Continuous(years) | Somatropin |
|---|
| Sex: Female, Male | Somatropin |
|---|---|
| Female | — |
| Male | — |
| Region of Enrollment(participants) | Somatropin |
|---|
This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Nationwide Children's Hospital