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Trial of Growth Hormone Therapy in Pediatric Crohn's Disease

Information source: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: growth hormone (Drug); cortecosteroid (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Children's Hospital Medical Center, Cincinnati

Official(s) and/or principal investigator(s):
Lee Denson, M.D., Principal Investigator, Affiliation: Children's Hospital Medical Center, Cincinnati


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.

Clinical Details

Official title: A Phase II Randomized Trial of Growth Hormone Therapy in Pediatric Crohn's Disease

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Crohn's Disease Histologic Index of Severity (CDHIS)

Secondary outcome:

Serum IGF-1 (Insulin-like Growth Factor 1)z Score


Pediatric Crohn's Disease Activity Index (PCDAI)

Total Corticosteroid Use

Crohn's Disease Endoscopic Index of Severity (CDEIS)

Height Velocity

Fecal Calprotectin

Detailed description: 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. This study also involves a 52 week extension phase where all participants that meet eligibility will be given the opportunity to take or continue taking growth hormone for 52 weeks.


Minimum age: 5 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Locations and Contacts

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States
Additional Information

Starting date: April 2005
Last updated: October 10, 2011

Page last updated: August 23, 2015

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