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.

Condition	Treatment or Intervention	Phase
Crohn's Disease	Drug: Somatropin, E-coli Derived	Phase II

Further Study Details: 

Primary Outcomes: Crohn's Disease Histologic Index of Severity
Secondary Outcomes: Serum IGF-1; Colon crypt epithelial cell (CEC) proliferation labeling index; IMPACT III; Pediatric Crohn's disease Activity Index; Total corticosteroid use; Intra-abdominal fat; Height velocity
Expected Total Enrollment:  28

The optimal treatment goals in childhood CD include: 1) clinical remission in conjunction with mucosal healing and 2) restoration of normal growth and development. Current therapy in most cases includes induction of remission with corticosteroids followed by maintenance of remission with 6-mercaptopurine (6-MP) or mesalamine. With this approach, the goals of achieving mucosal healing with normalization of growth are not achieved in a significant number of children. GH therapy is now used in several chronic childhood diseases which are complicated by growth failure despite adequate GH secretion. These include chronic renal failure (CRF), juvenile rheumatoid arthritis (JRA), and Turner’s syndrome. However, despite a comparable frequency and magnitude of permanent growth failure, the efficacy of GH therapy in this respect has not yet been determined in a controlled trial for CD. Moreover, whether GH therapy may also directly reduce disease activity and promote intestinal healing is not known. This represents a significant clinically unmet need in this patient population. Therefore, new therapeutic approaches are needed to both improve final adult height and enhance intestinal mucosal healing in children with CD.

The primary objective of this study is to determine the effect of growth hormone (GH) therapy upon colon mucosal healing in a 12 week randomized trial in children with Crohn’s Disease (CD). Children with active CD will be randomized to GH + prednisone (GP) or prednisone alone (P) for a 12 week period.

Ages Eligible for Study:  5 Years   -   18 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Ability to provide written informed consent
• Age > 5 years and ≤ 18 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.
• 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 or past therapy with infliximab as this may independently rapidly reduce clinical disease activity and promote mucosal healing
• Use of prednisone at 1 mg/kg for 3 weeks or more
• Use of prednisone at any other dose or use of budesonide at screening
• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00109473

Jeanie Bailey, MT (ASCP)      513-636-4946    jeanie.bailey@cchmc.org

Ohio
      Cincinnati Children's Hospital Medical Center, Cincinnati,  Ohio,  45229,  United States; Recruiting

Study ID Numbers:  CCHMC IRB #: 04-12-06; FDA IND#: 71344
Record last reviewed:  April 2005
Last Updated:  April 29, 2005
Record first received:  April 28, 2005
ClinicalTrials.gov Identifier:  NCT00109473
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-03