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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

Brief Summary:
The purpose of this study is to determine the safety and efficiency of Propranolol as an initial treatment for pediatric hemangioma.

Condition or disease Intervention/treatment Phase
Hemangioma Drug: Prednisolone Drug: Propranolol Phase 4

Detailed Description:
  • Randomized (A group : propranolol, B group : prednisolone)
  • A group : 3 days admission and medication for 16 weeks
  • B group : medication for 16 weeks without admission
  • Hemangioma volume comparison by using MRI
  • other measurement and drug adverse reaction monitoring

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma
Study Start Date : June 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015


Arm Intervention/treatment
Active Comparator: Prednisolone
Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks
Drug: Prednisolone
2mg/kg/day for 16weeks
Other Name: steroid

Experimental: Propranolol
Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks
Drug: Propranolol
2mg/kg/day for 16weeks
Other Name: beta-blocker




Primary Outcome Measures :
  1. Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO [ Time Frame: After 16weeks ]
    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.


Secondary Outcome Measures :
  1. Percent Reduction in Hemangioma Volume From Baseline [ Time Frame: After 16 weeks ]
    Percent Reduction in Hemangioma Volume from Baseline (measured by MRI or Sono (from basline to 16 weeks))

  2. 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 [ Time Frame: up to 16weeks ]
    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

  3. Number of Participants With Change in Color as Compared to Baseline [ Time Frame: After 16 weeks ]
    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

  4. Number of Participants With Size Reduction of Ulceration [ Time Frame: After 16 weeks ]
    size was measure the horizontal and vertical size (2-dimension) of ulceration (from baseline to 16 weeks after medication)

  5. Number of Participants With Reepithelialzation in 16weeks [ Time Frame: After 16 weeks ]
    Number of participants with Reepithelialzation in 16weeks..

  6. Number of Participants With Stop of Proliferation [ Time Frame: After 16 weeks ]
    Number of participants whose hemangioma stop proliferating in 16weeks

  7. Number of Participants With Regression [ Time Frame: Within 16 weeks ]
    Number of participants whose hemangioma showed regression in 16 weeks.

  8. Number of Participants With Drug Compliance Within 16 Weeks [ Time Frame: After 16 weeks ]
    We checked Number of participants with Drug compliance within 16 weeks

  9. 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 ]
    Number of Participants in Which, the Systolic blood pressure fall of >25% of baseline postdose with child awake, Anytime During the 16 Weeks..

  10. Number of Participants in Which, Glucose Levels Fall (to <50mg/dl), Anytime During the 16 Weeks [ Time Frame: up to 16weeks ]
    Number of Participants in Which, Glucose levels fall (to <50mg/dl), Anytime During the 16 Weeks..

  11. Number of Participants in Which, Facial Edema Occurs, Anytime During the 16 Weeks [ Time Frame: up to 16weeks ]
    Number of Participants in Which, facial edema occurs, Anytime During the 16 Weeks..

  12. Number of Participants With Growth Retardation Within 16 Weeks [ Time Frame: up to 16weeks ]
    Number of Participants with Growth Retardation within 16 weeks..

  13. Number of Participants With Gastroesophageal Reflux Within 16 Weeks [ Time Frame: up to 16weeks ]
    Number of Participants With Gastroesophageal reflux within 16 weeks..

  14. Number of Participants With Adverse Drug Reaction [ Time Frame: up to 16weeks ]
    All symptoms associated adverse drug reaction will be checked



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Ages Eligible for Study:   up to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hemangioma patient ( 0 ~ 9 months old)
  • No treatment before
  • 10 ~ 20 % volume increase in 2 ~ 4 weeks
  • Hemangioma that caused organ function
  • Hemangioma that will cause aesthetic problem

Exclusion Criteria:

  • Cardiovascular disease (impossible to use propranolol)
  • Drug adverse reaction or allergy history (propranolol, steroid)
  • Bradycardia, Atrioventricular block, atrial block
  • Cardiogenic Shock
  • Right heart failure (pulmonary hypertension)
  • Congestive heart failure
  • Hypotension
  • Peripheral nerve disease (moderate)
  • Angina
  • Hormone deficiency patient
  • Pulmonary disease (asthma)
  • diabetic ketoacidosis
  • laser treatment history

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908972


Locations
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Korea, Republic of
Seould National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Director: Kyung-Duk Park, MD, Ph D Seoul National University Hospital
Study Director: Tae Hyun Choi, MD, Ph D Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01908972     History of Changes
Other Study ID Numbers: 12172-MM-231
First Posted: July 26, 2013    Key Record Dates
Results First Posted: October 26, 2018
Last Update Posted: December 19, 2018
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Seoul National University Hospital:
Hemangioma
Propranolol
prednisolone
steroid

Additional relevant MeSH terms:
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Propranolol
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action