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Trial of Growth Hormone Therapy in Pediatric Crohn's Disease

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ClinicalTrials.gov Identifier: NCT00109473
Recruitment Status : Completed
First Posted : April 29, 2005
Results First Posted : September 16, 2011
Last Update Posted : January 12, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Crohn's Disease
Interventions: Drug: growth hormone
Drug: cortecosteroid

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
98 subjects were assessed for eligibility, 76 did not meet inclusion criteria, 21 refused to participate

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
21 subjects enrolled, one withdrew consent prior to randomization.

Reporting Groups
  Description
Growth Hormone Plus Corticosteroid (CTX) Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
Corticosteroid (CTX) Subjects took corticosteroid as prescribed by their physician

Participant Flow for 3 periods

Period 1:   Baseline (0 Through 12 Weeks)
    Growth Hormone Plus Corticosteroid (CTX)   Corticosteroid (CTX)
STARTED   10 [1]   10 
Analyzed   10   10 
COMPLETED   10   9 [2] 
NOT COMPLETED   0   1 
[1] 11 subjects allocated to Group A; one withdrew consent, only 10 receieved intervention.
[2] One subject discontinued intervention because of active disease requiring imfliximab

Period 2:   Week 12 to Week 24
    Growth Hormone Plus Corticosteroid (CTX)   Corticosteroid (CTX)
STARTED   10   9 
Analyzed   9   9 
COMPLETED   9 [1]   9 [2] 
NOT COMPLETED   1   0 
[1] One subject withdrew consent
[2] one subject discontinued intervention due to active disease requiring surgery

Period 3:   52 Week Extension Phase
    Growth Hormone Plus Corticosteroid (CTX)   Corticosteroid (CTX)
STARTED   9   8 
Analyzed   9   8 
COMPLETED   5 [1]   3 [1] 
NOT COMPLETED   4   5 
[1] Extension phase ends when subjects discontinue intervention due to active disease or reaches week 64



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Growth Hormone Plus Corticosteroid (CTX) Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
Corticosteroid (CTX) Subjects took corticosteroid as prescribed by their physician
Total Total of all reporting groups

Baseline Measures
   Growth Hormone Plus Corticosteroid (CTX)   Corticosteroid (CTX)   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age, Customized 
[Units: Participants]
     
<=18 years   10   10   20 
Age 
[Units: Years]
Mean (Standard Deviation)
 12  (3)   13  (3)   13  (3) 
Gender 
[Units: Participants]
Count of Participants
     
Female      2  20.0%      2  20.0%      4  20.0% 
Male      8  80.0%      8  80.0%      16  80.0% 
Region of Enrollment 
[Units: Participants]
     
United States   10   10   20 


  Outcome Measures

1.  Primary:   Crohn's Disease Histologic Index of Severity (CDHIS)   [ Time Frame: Baseline and 12 weeks ]

2.  Secondary:   Serum IGF-1 (Insulin-like Growth Factor 1)z Score   [ Time Frame: Baseline, 12 weeks, 24 weeks ]

3.  Secondary:   IMPACT III Score   [ Time Frame: Baseline, 12 weeks, 24 weeks ]

4.  Secondary:   Pediatric Crohn's Disease Activity Index (PCDAI)   [ Time Frame: Baseline, 12 and 24 weeks ]

5.  Secondary:   Crohn's Disease Endoscopic Index of Severity (CDEIS)   [ Time Frame: Baseline and 12 weeks ]

6.  Secondary:   Height Velocity   [ Time Frame: Baseline, week 12, 24 and 48 ]

7.  Secondary:   Fecal Calprotectin   [ Time Frame: At 24 and 64 weeks ]

8.  Secondary:   Total Corticosteroid Use   [ Time Frame: 12 weeks, 24 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lee A. Denson
Organization: Cincinnati Children's Hospital Medical Center
phone: 513-636-7575
e-mail: lee.denson@cchmc.org



Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00109473     History of Changes
Other Study ID Numbers: CCHMC IRB #: 04-12-06
IND # 71,344 ( Other Identifier: FDA )
First Submitted: April 28, 2005
First Posted: April 29, 2005
Results First Submitted: June 24, 2011
Results First Posted: September 16, 2011
Last Update Posted: January 12, 2017