Phase 2
N=20
Trial of Growth Hormone Therapy in Pediatric Crohn's Disease
Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00109473 ↗Enrolled (actual)
20
Serious AEs
8.1%
Results posted
Sep 2011
Primary outcome: Primary: Crohn's Disease Histologic Index of Severity (CDHIS) — 7; 8; 6; 8 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- growth hormone (Drug); cortecosteroid (Drug)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Crohn's Disease Histologic Index of Severity (CDHIS) |
7; 8; 6; 8 | — |
| SECONDARY Serum IGF-1 (Insulin-like Growth Factor 1)z Score |
-0.4; -0.7; 1.8; -1; 3.3; 3.8 | — |
| SECONDARY IMPACT III Score |
134; 132; 143; 136 | — |
| SECONDARY Pediatric Crohn's Disease Activity Index (PCDAI) |
32; 33; 8; 22; 9; 6 | 0.02 sig |
| SECONDARY Total Corticosteroid Use |
22; 28; 7; 8 | — |
| SECONDARY Crohn's Disease Endoscopic Index of Severity (CDEIS) |
9; 8; 3; 6 | — |
| SECONDARY Height Velocity |
5; 3; 8; 3; 9; 7 | — |
| SECONDARY Fecal Calprotectin |
863; 904; 868; 656 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Ability to provide written informed consent
- Age ≥ 5 years.
- Diagnosis of Crohn's disease (CD) with ileo-colonic involvement as determined by standard clinical, radiological, and pathological criteria.
- Moderate to severely active CD as defined by a PCDAI (Pediatric Crohn's Disease Activity Index) ≥ 30.
- Currently taking Prednisone or Budesonide at starting dose (not tapering)
- May continue stable doses of AZA/6-MP, methotrexate, and/or mesalamine at entry.
- For the 52 week extension, baseline bone age ≤ 12 years for girls and ≤ 13 years for boys.
- For the 52 week extension phase, remission or mild Crohn's disease as determined by a PCDAI < 30.
Exclusion Criteria
- Acute critical illness
- Active neoplasia
- Diabetes mellitus
- History of intracranial lesion and/or neoplasia
- Severe disease requiring hospitalization for treatment
- Current therapy with infliximab as this may independently rapidly reduce clinical disease activity and promote mucosal healing
- Use of prednisone or budesonide and in tapering phase
- Family history of colorectal cancer before age 50
- Personal or familial history of familial polyposis syndrome
- Pregnancy (positive pregnancy test) prior to randomization
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial other than the Pediatric IBD (Inflammatory Bowel Disease) registry
Data sourced from ClinicalTrials.gov (NCT00109473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.