At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 22 enrolled
Drug / intervention
growth hormone +1 moredrug
Likely dose
Nutropin AQ 0.075 mg/kg/day subcutaneously dailyAI-extracted
Key inclusion· 5
- ✓Age ≥5 years
- ✓Diagnosis of Crohn's disease with ileo-colonic involvement confirmed by clinical, radiological, and pathological criteria
- ✓Moderate to severely active disease defined by PCDAI ≥30
- ✓Currently taking prednisone or budesonide at starting dose (not tapering)
Key exclusion· 8
- ✕Active neoplasia or history of intracranial lesion/neoplasia
- ✕Diabetes mellitus
- ✕Severe disease requiring hospitalization for treatment
- ✕Current therapy with infliximab
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Randomized Trial of Growth Hormone Therapy in Pediatric Crohn's Disease
Children's Hospital Medical Center, Cincinnati·interventional·Posted Apr 29, 2005·Updated Oct 30, 2020
In Brief
A Phase 2 clinical trial evaluating growth hormone and cortecosteroid for Crohn's Disease. Completed, enrolled 22 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether taking a growth hormone (GH) drug called somatropin causes the intestine of a person with Crohn's Disease (CD) to heal faster when compared to a person with Crohn's Disease that does not receive growth hormone drug.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesUnited States
CollaboratorsGenentech, Inc.
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2005
First PostedApr 2005
Primary CompletionJul 2009
Study CompletionAug 2009
TodayJul 2026
First PostedApr 29, 2005
Enrollment StartApr 1, 2005
Primary CompletionJul 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 21.2 years ago
Interventions
growth hormonedrug
Nutropin AQ 0.075mg/kg/day subcutaneously daily
cortecosteroiddrug
As prescribed by the referring gastroenterologist