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The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma

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ClinicalTrials.gov Identifier: NCT01908972
Recruitment Status : Completed
First Posted : July 26, 2013
Results First Posted : October 26, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Hemangioma
Interventions Drug: Prednisolone
Drug: Propranolol
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prednisolone Propranolol
Hide Arm/Group Description

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

Period Title: Overall Study
Started 17 17
Completed 15 17
Not Completed 2 0
Arm/Group Title Prednisolone Propranolol Total
Hide Arm/Group Description

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

Total of all reporting groups
Overall Number of Baseline Participants 17 17 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
<=18 years
17
 100.0%
17
 100.0%
34
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Months
Number Analyzed 17 participants 17 participants 34 participants
3.0
(0.8 to 8.0)
3.6
(0.3 to 8.2)
3.3
(0.3 to 8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
Female
9
  52.9%
10
  58.8%
19
  55.9%
Male
8
  47.1%
7
  41.2%
15
  44.1%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
South Korea Number Analyzed 17 participants 17 participants 34 participants
17
 100.0%
17
 100.0%
34
 100.0%
Hemangioma volume by MRI  
Mean (Standard Deviation)
Unit of measure:  Mm^3
Number Analyzed 17 participants 17 participants 34 participants
9,349  (16,015) 14,125  (18,246) 11,737  (3348)
1.Primary Outcome
Title Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO
Hide Description The primary efficacy variable was the clinical response at 16 weeks, classified as follows: when the volume did not increase or decreased by less than 25% after treatment began, we defined it as stop of progression; when the volume decreased by 25% or more compared with the original size, we defined it as regression. Both stop of progression and regressionwere defined as reaction. If the volume at the primary efficacy evaluation point was greater than the size measured when treatment started,we called it an increase. Increase was defined as a nonreaction.
Time Frame After 16weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prednisolone Propranolol
Hide Arm/Group Description:

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
14
  82.4%
16
  94.1%
2.Secondary Outcome
Title Percent Reduction in Hemangioma Volume From Baseline
Hide Description Percent Reduction in Hemangioma Volume from Baseline (measured by MRI or Sono (from basline to 16 weeks))
Time Frame After 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prednisolone Propranolol
Hide Arm/Group Description:

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: % from baseline
46.52  (26.24) 55.87  (18.92)
3.Secondary Outcome
Title Number of Participants in Which, the Heart Rate Fell to <70% of Acceptable Age Related Minimum Post-dose With Child Awake, Anytime During the 16 Weeks
Hide Description Number of Participants in which, the Heart rate fell to <70% of acceptable age related minimum post-dose with child awake, anytime during the 16 weeks Count of patients whose Heart rate fall to <70% of acceptable age related minimum post-dose with child awake
Time Frame up to 16weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prednisolone Propranolol
Hide Arm/Group Description:

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

Overall Number of Participants Analyzed 15 17
Measure Type: Count of Participants
Unit of Measure: Participants
1 5
4.Secondary Outcome
Title Number of Participants With Change in Color as Compared to Baseline
Hide Description Participants were observed for any change in color. The possible change in colors included change to Red/Purple/Blue/Gray/Apricot. Reported are the number of participants who experienced a change in color by the type of color
Time Frame After 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prednisolone Propranolol
Hide Arm/Group Description:

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

Overall Number of Participants Analyzed 15 17
Measure Type: Count of Participants
Unit of Measure: Participants
Red
13
  86.7%
14
  82.4%
Purple
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Number of Participants With Size Reduction of Ulceration
Hide Description size was measure the horizontal and vertical size (2-dimension) of ulceration (from baseline to 16 weeks after medication)
Time Frame After 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prednisolone Propranolol
Hide Arm/Group Description:

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
2
  11.8%
1
   5.9%
6.Secondary Outcome
Title Number of Participants With Reepithelialzation in 16weeks
Hide Description Number of participants with Reepithelialzation in 16weeks..
Time Frame After 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prednisolone Propranolol
Hide Arm/Group Description:

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
4
  23.5%
8
  47.1%
7.Secondary Outcome
Title Number of Participants With Stop of Proliferation
Hide Description Number of participants whose hemangioma stop proliferating in 16weeks
Time Frame After 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prednisolone Propranolol
Hide Arm/Group Description:

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
15
  88.2%
17
 100.0%
8.Secondary Outcome
Title Number of Participants With Regression
Hide Description Number of participants whose hemangioma showed regression in 16 weeks.
Time Frame Within 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prednisolone Propranolol
Hide Arm/Group Description:

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
9
  52.9%
13
  76.5%
9.Secondary Outcome
Title Number of Participants With Drug Compliance Within 16 Weeks
Hide Description We checked Number of participants with Drug compliance within 16 weeks
Time Frame After 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prednisolone Propranolol
Hide Arm/Group Description:

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
15
  88.2%
17
 100.0%
10.Secondary Outcome
Title Number of Participants in Which, the Systolic Blood Pressure Fall of >25% of Baseline Postdose With Child Awake, Anytime During the 16 Weeks
Hide Description Number of Participants in Which, the Systolic blood pressure fall of >25% of baseline postdose with child awake, Anytime During the 16 Weeks..
Time Frame up to 16weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prednisolone Propranolol
Hide Arm/Group Description:

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.9%
5
  29.4%
11.Secondary Outcome
Title Number of Participants in Which, Glucose Levels Fall (to <50mg/dl), Anytime During the 16 Weeks
Hide Description Number of Participants in Which, Glucose levels fall (to <50mg/dl), Anytime During the 16 Weeks..
Time Frame up to 16weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prednisolone Propranolol
Hide Arm/Group Description:

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Number of Participants in Which, Facial Edema Occurs, Anytime During the 16 Weeks
Hide Description Number of Participants in Which, facial edema occurs, Anytime During the 16 Weeks..
Time Frame up to 16weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prednisolone Propranolol
Hide Arm/Group Description:

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
5
  29.4%
0
   0.0%
13.Secondary Outcome
Title Number of Participants With Growth Retardation Within 16 Weeks
Hide Description Number of Participants with Growth Retardation within 16 weeks..
Time Frame up to 16weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prednisolone Propranolol
Hide Arm/Group Description:

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
2
  11.8%
0
   0.0%
14.Secondary Outcome
Title Number of Participants With Gastroesophageal Reflux Within 16 Weeks
Hide Description Number of Participants With Gastroesophageal reflux within 16 weeks..
Time Frame up to 16weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prednisolone Propranolol
Hide Arm/Group Description:

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
15.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction
Hide Description All symptoms associated adverse drug reaction will be checked
Time Frame up to 16weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prednisolone Propranolol
Hide Arm/Group Description:

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
15
  88.2%
16
  94.1%
Time Frame 20 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prednisolone Propranolol
Hide Arm/Group Description

Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks

Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks

All-Cause Mortality
Prednisolone Propranolol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Prednisolone Propranolol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/17 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prednisolone Propranolol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/17 (5.88%)      5/17 (29.41%)    
Blood and lymphatic system disorders     
Bradycardia  [1]  1/17 (5.88%)  1 5/17 (29.41%)  5
Indicates events were collected by systematic assessment
[1]
Blood pressure <25%

Although the sample size in the present study was predetermined to show noninferiority, it is difficult to provide strong evidence of safety outcomes.

The present study was not a double-blind trial.

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
Layout table for Results Point of Contact information
Name/Title: Prof. Tae Hyun Choi
Organization: Seoul National University College of Medicine
Phone: 82-10-5595-5829
EMail: psthchoi@snu.ac.kr
Layout table for additonal information
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01908972     History of Changes
Other Study ID Numbers: 12172-MM-231
First Submitted: July 9, 2013
First Posted: July 26, 2013
Results First Submitted: October 29, 2017
Results First Posted: October 26, 2018
Last Update Posted: December 19, 2018