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.

Official Title

A Phase II Randomized Trial of Growth Hormone Therapy in Pediatric Crohn’s Disease.

Conditions

  •  Crohn’s Disease

Study Type

Interventional

Study Design

Treatment, Randomised, Open Label, Active Control, Parallel Assignment, Efficacy Study.

Further Details

Primary Outcome Measures:

  • The primary endpoint will be the CD histologic index of severity (CDHIS)

Secondary Outcome Measures:

  • Serum IGF-1
  • Colon crypt epithelial cell (CEC) proliferation labeling index
  • IMPACT III
  • Paediatric Crohn’s Disease Activity Index
  • Total corticosteroid use
  • Intra-abdominal fat 
  • Height velocity
  • Fecal calprotectin

Study Start

April 2005

Eligibility & Criteria

  • Ages Eligible for Study: 5 years and older
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers: No

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 (Paediatric 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 hospitalisation 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 randomisation
  • 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 Paediatric IBD (Inflammatory Bowel Disease) registry.

Total Enrolment

28

Contact Details

Lee Denson, MD
Children’s Hospital Medical Center, Cincinnati

Location:

Cincinnati Children’s Hospital Medical Center
Cincinnati, Ohio
United States
45229