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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01908972
First received: July 9, 2013
Last updated: February 15, 2016
Last verified: February 2016
  Purpose
The purpose of this study is to determine the safety and efficiency of Propranolol as an initial treatment for pediatric hemangioma.

Condition Intervention Phase
Hemangioma
Drug: Prednisolone
Drug: Propranolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Hemangioma volume measured by MRI or SONO [ Time Frame: After 16weeks ] [ Designated as safety issue: No ]
    We compared hemangioma volume measured by MRI or SONO, before and 16 weeks after medications.


Secondary Outcome Measures:
  • Size changes from baseline [ Time Frame: After 16 weeks ] [ Designated as safety issue: No ]
    Measure the horizontal and vertical size (2-dimension)

  • Heart rate change from Baseline at 16 weeks [ Time Frame: up to 16weeks ] [ Designated as safety issue: Yes ]
    Heart rate fall to <70% of acceptable age related minimum post-dose with child awake

  • Change from Baseline in color [ Time Frame: After 16 weeks ] [ Designated as safety issue: No ]
    Red/Purple/Blue/Gray/Apricot

  • Changes in Size of Ulceration [ Time Frame: After 16 weeks ] [ Designated as safety issue: No ]
    Measure the horizontal and vertical size (2-dimension)

  • Whether or not Re-epithelized in 16weeks [ Time Frame: After 16 weeks ] [ Designated as safety issue: No ]
    Yes/No

  • Stop time of proliferation [ Time Frame: After 16 weeks ] [ Designated as safety issue: No ]
    The time when hemangioma stop growing within 16 weeks

  • Time of regression [ Time Frame: Within 16 weeks ] [ Designated as safety issue: No ]
    The time when hemangioma decreased to 75% of baseline size

  • Drug compliance within 16 weeks [ Time Frame: After 16 weeks ] [ Designated as safety issue: No ]
    Check the number of having drugs and skip time.

  • Change from Baseline in systolic blood pressure at 16 weeks [ Time Frame: up to 16weeks ] [ Designated as safety issue: Yes ]
    Systolic blood pressure fall of >25% of baseline postdose with child awake

  • Changes from baseline in Glucose level at 16 weeks [ Time Frame: up to 16weeks ] [ Designated as safety issue: Yes ]
    Check the Glucose level whether to fall (to <50mg/dl)

  • Whether the facial edema occurs within 16 weeks [ Time Frame: up to 16weeks ] [ Designated as safety issue: Yes ]
    Yes/No

  • Whether growth retardation occurs within 16 weeks [ Time Frame: up to 16weeks ] [ Designated as safety issue: Yes ]
    When the subject do not grow in 16 weeks at all.

  • Whether the Gastroesophageal reflux occurs within 16 weeks [ Time Frame: up to 16weeks ] [ Designated as safety issue: Yes ]
    Yes/No

  • Number of Participants with Adverse drug reaction [ Time Frame: up to 16weeks ] [ Designated as safety issue: Yes ]
    All symptoms associated adverse drug reaction will be checked


Enrollment: 34
Study Start Date: June 2013
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   up to 9 Months   (Child)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01908972

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

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01908972     History of Changes
Other Study ID Numbers: 12172-MM-231 
Study First Received: July 9, 2013
Last Updated: February 15, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes

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

Additional relevant MeSH terms:
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Propranolol
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

ClinicalTrials.gov processed this record on September 26, 2016