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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
Enrollment 22
Recruitment Details 98 subjects were assessed for eligibility, 76 did not meet inclusion criteria, 21 refused to participate
Pre-assignment Details 21 subjects enrolled, one withdrew consent prior to randomization.
Arm/Group Title Growth Hormone Plus Corticosteroid (CTX) Corticosteroid (CTX)
Hide Arm/Group Description Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily) Subjects took corticosteroid as prescribed by their physician
Period Title: Baseline (0 Through 12 Weeks)
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 Title: Week 12 to Week 24
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 Title: 52 Week Extension Phase
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
Arm/Group Title Growth Hormone Plus Corticosteroid (CTX) Corticosteroid (CTX) Total
Hide Arm/Group Description Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily) Subjects took corticosteroid as prescribed by their physician Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
<=18 years Number Analyzed 10 participants 10 participants 20 participants
10 10 20
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
12  (3) 13  (3) 13  (3)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
2
  20.0%
2
  20.0%
4
  20.0%
Male
8
  80.0%
8
  80.0%
16
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Crohn's Disease Histologic Index of Severity (CDHIS)
Hide Description The CDHIS was developed and validated in order to determine the effect of therapies upon histologic disease activity in Crohn's Disease. It has been used to assess mucosal healing in response to infliximab and 6-MP/AZA.It contains eight items which reflect epithelial injury, mucosal inflammation, and the extent of involvement. Scores range from 0-16, with patients with moderate to severely active CD typically having scores of 6-12. It was computed by a GI pathologist. The higher the score indicates worsening of disease, the lowest score is 0 and highest possible is 16
Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Growth Hormone Plus Corticosteroid (CTX) Corticosteroid (CTX)
Hide Arm/Group Description:
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
Subjects took corticosteroid as prescribed by their physician
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: scores on a scale
Baseline
7
(5 to 9)
8
(6 to 10)
Week 12
6
(4 to 8)
8
(5 to 10)
2.Secondary Outcome
Title Serum IGF-1 (Insulin-like Growth Factor 1)z Score
Hide Description

Elevated serum IGF-1 levels have been implicated in the development of colorectal cancer, both in the general population and in patients with an excess of growth hormone production. The serum IGF-1 levels were monitored to maintain them in the physiologic range during growth hormone therapy to reduce the risk of tumorigenesis.

The levels are reported as a z score, a statistical way of standardizing data. The standard deviation is the unit of measurement of the z-score. Each z score corresponds to a point in a normal distribution, describing how much a point deviates from a mean.

Time Frame Baseline, 12 weeks, 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Growth Hormone Plus Corticosteroid (CTX) Corticosteroid (CTX)
Hide Arm/Group Description:
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
Subjects took corticosteroid as prescribed by their physician
Overall Number of Participants Analyzed 10 10
Mean (Standard Error)
Unit of Measure: Z score
Baseline -0.4  (0.6) -0.7  (0.3)
Week 12 1.8  (1) -1  (0.3)
Week 24 3.3  (1.5) 3.8  (1)
3.Secondary Outcome
Title IMPACT III Score
Hide Description Health-related quality of life (QOL)was assessed using the IMPACT 111 questionnnaire. It is a self-administered 35 item questionnaire which typically takes 10-15 minutes to complete. Scores range from 0-350, with higher scores reflecting better perceived quality of life.
Time Frame Baseline, 12 weeks, 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Growth Hormone Plus Corticosteroid (CTX) Corticosteroid (CTX)
Hide Arm/Group Description:
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
Subjects took corticosteroid as prescribed by their physician
Overall Number of Participants Analyzed 10 10
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Baseline
134
(120 to 148)
132
(119 to 146)
Week 12
143
(129 to 157)
136
(123 to 150)
4.Secondary Outcome
Title Pediatric Crohn's Disease Activity Index (PCDAI)
Hide Description The PCDAI is a previously validated measure of clinical disease activity for children with CD. It contains three self-report items which reflect patient abdominal pain, diarrhea, and general well being; three laboratory values; height and weight velocity; and three physical examination parameters reflecting abdominal tenderness, perirectal disease, and extra-intestinal manifestations. Scores may range from 0-100. Remission is defined as 0-10, mild disease as 10-30, and moderate to severe disease as greater than 30.
Time Frame Baseline, 12 and 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Growth Hormone Plus Corticosteroid (CTX) Corticosteroid (CTX)
Hide Arm/Group Description:
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
Subjects took corticosteroid as prescribed by their physician
Overall Number of Participants Analyzed 10 10
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Baseline
32
(20 to 43)
33
(25 to 40)
Week 12
8
(2 to 14)
22
(14 to 30)
Week 24
9
(2 to 14)
6
(1 to 10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Growth Hormone Plus Corticosteroid (CTX), Corticosteroid (CTX)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Total Corticosteroid Use
Hide Description [Not Specified]
Time Frame 12 weeks, 24 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Crohn's Disease Endoscopic Index of Severity (CDEIS)
Hide Description Measure of mucosal disease at baseline and week 12 obtained during colonoscopy. The CDEIS score generally ranges from 0–30. A higher score indicates more severe mucosal inflammation.
Time Frame Baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Growth Hormone Plus Corticosteroid (CTX) Corticosteroid (CTX)
Hide Arm/Group Description:
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
Subjects took corticosteroid as prescribed by their physician
Overall Number of Participants Analyzed 10 10
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Baseline
9
(-1 to 18)
8
(2 to 13)
Week 12
3
(1 to 6)
6
(1 to 12)
7.Secondary Outcome
Title Height Velocity
Hide Description

Height velocity was computed every 12 weeks up to week 64 and then yearly during the Maintenance study. Since 40 to 80% of children with Crohn's disease have significant growth failure at diagnosis, height velocity is used to track for changes in height.

It is calculated by measuring height at two points of time and then dividing the change by the amount of time.

Time Frame Baseline, week 12, 24 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Growth Hormone Plus Corticosteroid (CTX) Corticosteroid (CTX)
Hide Arm/Group Description:
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
Subjects took corticosteroid as prescribed by their physician
Overall Number of Participants Analyzed 10 10
Mean (Standard Error)
Unit of Measure: cm/year
Baseline 5  (1) 3  (1)
Week 12 8  (1) 3  (1)
Week 24 9  (1) 7  (1)
8.Secondary Outcome
Title Fecal Calprotectin
Hide Description Fecal calprotectin is a previously validated stool marker of intestinal inflammation in Crohn's Disease.
Time Frame At 24 and 64 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Growth Hormone Plus Corticosteroid (CTX) Corticosteroid (CTX)
Hide Arm/Group Description:
Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
Subjects took corticosteroid as prescribed by their physician
Overall Number of Participants Analyzed 10 10
Mean (95% Confidence Interval)
Unit of Measure: micrograms per gram (microg/g)
Baseline
863
(517 to 1209)
904
(540 to 1269)
Week 12
868
(523 to 1214)
656
(310 to 1002)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Growth Hormone Plus Corticosteroid (CTX) Corticosteroid (CTX) Extension Phase
Hide Arm/Group Description Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily) Subjects took corticosteroid as recommended by their physician Eligible subjects from both group A and group B continued on growth hormone in a 52 week extension phase
All-Cause Mortality
Growth Hormone Plus Corticosteroid (CTX) Corticosteroid (CTX) Extension Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Growth Hormone Plus Corticosteroid (CTX) Corticosteroid (CTX) Extension Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/10 (10.00%)      0/10 (0.00%)      2/17 (11.76%)    
General disorders       
Abdominal Pain  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Hepatobiliary disorders       
Pancreatitis  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Skin and subcutaneous tissue disorders       
Bruising at injection site  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/17 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Growth Hormone Plus Corticosteroid (CTX) Corticosteroid (CTX) Extension Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/10 (100.00%)      10/10 (100.00%)      17/17 (100.00%)    
Blood and lymphatic system disorders       
ANC elevated  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Basophils elevated  1  1/10 (10.00%)  1 0/10 (0.00%)  0 1/17 (5.88%)  1
Decreased hematocrit  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Eosinophils elevated  1  0/10 (0.00%)  0 1/10 (10.00%)  1 3/17 (17.65%)  3
Ferritin decrease  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Hematocrit decreased  1  0/10 (0.00%)  0 1/10 (10.00%)  1 1/17 (5.88%)  1
Hematocrit elevated  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/17 (0.00%)  0
Hemoglobin decreased  1  2/10 (20.00%)  2 3/10 (30.00%)  3 1/17 (5.88%)  1
Iron level decreased  1  0/10 (0.00%)  0 0/10 (0.00%)  0 2/17 (11.76%)  2
Iron level elevated  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Leukocyte count decreased  1  1/10 (10.00%)  1 1/10 (10.00%)  1 0/17 (0.00%)  0
Lymphocyte count decreased  1  3/10 (30.00%)  3 1/10 (10.00%)  1 0/17 (0.00%)  0
Lymphocytes elevated  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/17 (0.00%)  0
Monocytes elevated  1  2/10 (20.00%)  2 2/10 (20.00%)  2 3/17 (17.65%)  4
RBC decreased  1  1/10 (10.00%)  1 0/10 (0.00%)  0 2/17 (11.76%)  2
RBC elevated  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
RDW elevated  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Sedimentation Rate Elevated  1  0/10 (0.00%)  0 0/10 (0.00%)  0 2/17 (11.76%)  2
Segs elevated  1  0/10 (0.00%)  0 0/10 (0.00%)  0 2/17 (11.76%)  2
Thrombocytosis  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Fatigue  1  1/10 (10.00%)  1 2/10 (20.00%)  2 3/17 (17.65%)  3
Eye disorders       
Eye irritation  1  1/10 (10.00%)  1 1/10 (10.00%)  1 0/17 (0.00%)  0
Gastrointestinal disorders       
Anal fissure  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/17 (0.00%)  0
Anorexia  1  0/10 (0.00%)  0 1/10 (10.00%)  1 3/17 (17.65%)  3
Colitis  1  0/10 (0.00%)  0 0/10 (0.00%)  0 2/17 (11.76%)  2
Constipation  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Dehydration  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/17 (0.00%)  0
Diarrhea  1  3/10 (30.00%)  3 1/10 (10.00%)  1 10/17 (58.82%)  11
Dyspepsia  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Enteritis  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/17 (0.00%)  0
Fecal urgency  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
hemorrhoids  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/17 (0.00%)  0
Nausea  1  2/10 (20.00%)  2 3/10 (30.00%)  3 5/17 (29.41%)  6
Vomiting  1  2/10 (20.00%)  2 3/10 (30.00%)  3 6/17 (35.29%)  8
Hemorrhage nasal  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/17 (0.00%)  0
Lower gastrointestinal hemorrhage  1  2/10 (20.00%)  2 0/10 (0.00%)  0 0/17 (0.00%)  0
General disorders       
Fever  1  2/10 (20.00%)  3 2/10 (20.00%)  2 8/17 (47.06%)  8
Increased thirst  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Insomnia  1  1/10 (10.00%)  1 0/10 (0.00%)  0 1/17 (5.88%)  1
Weight loss  1  0/10 (0.00%)  0 1/10 (10.00%)  1 3/17 (17.65%)  3
Abdominal Pain  1  1/10 (10.00%)  3 1/10 (10.00%)  1 7/17 (41.18%)  7
Back pain  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/17 (0.00%)  0
Breast pain  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/17 (0.00%)  0
Chest pain  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/17 (0.00%)  0
Headache  1  1/10 (10.00%)  1 4/10 (40.00%)  4 3/17 (17.65%)  3
Joint Pain  1  6/10 (60.00%)  6 1/10 (10.00%)  1 3/17 (17.65%)  3
Myalgia  1  0/10 (0.00%)  0 1/10 (10.00%)  1 2/10 (20.00%)  2
Pain in extremity  1  2/10 (20.00%)  2 0/10 (0.00%)  0 1/17 (5.88%)  1
Pharyngolaryngeal pain  1  1/10 (10.00%)  1 2/10 (20.00%)  2 2/17 (11.76%)  2
Rectal pain  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Shoulder  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/17 (0.00%)  0
Cough  1  2/10 (20.00%)  2 4/10 (40.00%)  4 2/17 (11.76%)  2
Sinus congestion  1  0/10 (0.00%)  0 1/10 (10.00%)  3 1/17 (5.88%)  1
Dysuria  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Immune system disorders       
Allergic Rhinitis  1  2/10 (20.00%)  2 0/10 (0.00%)  0 3/17 (17.65%)  3
Hypersensitivity  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/17 (0.00%)  0
Lactose intolerant  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/17 (0.00%)  0
Infections and infestations       
Colitis, infectious  1  0/10 (0.00%)  0 1/10 (10.00%)  1 1/17 (5.88%)  1
Gastric infection  1  1/10 (10.00%)  1 0/10 (0.00%)  0 3/17 (17.65%)  5
Oral thrush infection  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Pharyngitis  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Sinusitis  1  1/10 (10.00%)  1 0/10 (0.00%)  0 1/17 (5.88%)  1
Skin Infection  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Upper respiratory infection  1  1/10 (10.00%)  1 0/10 (0.00%)  0 1/17 (5.88%)  1
Vaginal Infection  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Metabolism and nutrition disorders       
ALT decreased  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
ALT increased  1  1/10 (10.00%)  1 0/10 (0.00%)  0 3/17 (17.65%)  3
AST increased  1  0/10 (0.00%)  0 0/10 (0.00%)  0 7/17 (41.18%)  9
Alkaline phosphate decreased  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Anion gap high  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/17 (0.00%)  0
Anti-mitochondrial antibody  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
BUN  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/17 (0.00%)  0
BUN decreased  1  4/10 (40.00%)  5 0/10 (0.00%)  0 2/17 (11.76%)  2
BUN elevated  1  2/10 (20.00%)  2 0/10 (0.00%)  0 1/17 (5.88%)  1
Bilirubin increased  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Blood bicarbonate decreased  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/17 (0.00%)  0
Blood bicarbonate elevated  1  1/10 (10.00%)  1 0/10 (0.00%)  0 5/17 (29.41%)  6
Blood glucose decreased  1  3/10 (30.00%)  3 1/10 (10.00%)  1 0/17 (0.00%)  0
Blood glucose increased  1  0/10 (0.00%)  0 0/10 (0.00%)  0 2/17 (11.76%)  2
CRP elevated  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Chloride elevated  1  1/10 (10.00%)  1 1/10 (10.00%)  1 2/10 (20.00%)  2
Creatnine decreased  1  4/10 (40.00%)  5 1/10 (10.00%)  1 3/17 (17.65%)  3
Creatinine elevated  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/17 (0.00%)  0
Hyperinsulinemia  1  0/10 (0.00%)  0 0/10 (0.00%)  0 5/17 (29.41%)  6
Serum albumin decreased  1  1/10 (10.00%)  1 1/10 (10.00%)  1 0/17 (0.00%)  0
Serum potassium decreased  1  3/10 (30.00%)  3 3/10 (30.00%)  3 1/17 (5.88%)  1
Serum potassium increased  1  0/10 (0.00%)  0 0/10 (0.00%)  0 2/17 (11.76%)  2
Serum sodium decreased  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/17 (0.00%)  0
Serum triglycerides increased  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Urine calcium decreased  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/17 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Fracture  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Joint disorder  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Nervous system disorders       
Anxiety  1  1/10 (10.00%)  2 0/10 (0.00%)  0 1/17 (5.88%)  1
Concussion  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Peripheral sensory neuropathy  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/17 (0.00%)  0
Depression  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/17 (0.00%)  0
Skin and subcutaneous tissue disorders       
Bruising at injection site  1  4/10 (40.00%)  5 2/10 (20.00%)  2 5/17 (29.41%)  9
Injection site reaction  1  1/10 (10.00%)  1 1/10 (10.00%)  1 0/17 (0.00%)  0
Insect bite  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/17 (0.00%)  0
Milia  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Rash acneiform  1  2/10 (20.00%)  2 1/10 (10.00%)  1 1/17 (5.88%)  1
Rash desquamating  1  0/10 (0.00%)  0 0/10 (0.00%)  0 3/17 (17.65%)  3
Seborrhea  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Skin hypopigmentation  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Skin striae  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/17 (5.88%)  1
Cushingoid  1  6/10 (60.00%)  6 2/10 (20.00%)  2 2/17 (11.76%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
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