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NCT00764699 · ClinicalTrials.gov registry record · Phase 2
Effect of Increlex® on Children With Crohn Disease
A Phase 2 study, sponsored by Nationwide Children's Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT00764699 is a Phase 2 study that was terminated before completion, run by Nationwide Children's Hospital. The registered enrollment target is 3 participants.
The verdict
NCT00764699, a Phase 2 study, was terminated before completion, sponsored by Nationwide Children's Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
Patients with Crohn disease often have poor weight gain and short stature, yet the etiology of the poor growth is not well defined. Studies in chronically ill patients who do not have Crohn disease have suggested that inflammation causes IGF-1 deficiency due to inadequate IGF-1 generation. Previous studies of GH use in Crohn patients have demonstrated improvement in linear growth, weight and bone mineralization. However, GH can cause glucose intolerance in chronically ill children, particularly those who require treatment with corticosteroids. Recently the FDA has approved recombinant IGF-1 (rhIGF) for treatment of IGF-1 deficient short stature. This medication has not been studied in Crohn disease. The purpose of this study is to test the hypothesis that poor growth in Crohn disease is associated abnormal IGF-1 generation which leads to poor linear growth, decreased weight and osteoporosis and that replacement of IGF-1 with rhIGF will correct growth and improve bone density. To test our hypothesis we will recruit 20 patients with Crohn disease from our pediatric gastroenterology practice. Each will have been previously diagnosed with Crohn disease for a minimum of one year and will be studied at baseline and six month intervals for one year while on treatment with Increlex.
Interventions
- DRUG rhIGF (Increlex)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2008-10 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00764699
The ClinicalTrials.gov registry entry for NCT00764699 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which rhIGF (Increlex) is the first listed.
NCT00764699 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00764699 about?
NCT00764699 is a clinical study titled "Effect of Increlex® on Children With Crohn Disease". Patients with Crohn disease often have poor weight gain and short stature, yet the etiology of the poor growth is not well defined. Studies in chronically ill patients who do not have Crohn disease have suggested that inflammation causes IGF-1 deficiency due to inadequate IGF-1 generation. Previous ...
What is the current status of trial NCT00764699?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2008-10. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00764699?
The interventions under investigation include: rhIGF (Increlex) (DRUG).
Who is sponsoring clinical trial NCT00764699?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
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