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Nadolol Versus Propranolol in Children With Infantile Hemangiomas

This study is currently recruiting participants.
Verified January 2016 by Elena Pope, The Hospital for Sick Children
Sponsor:
ClinicalTrials.gov Identifier:
NCT02505971
First Posted: July 22, 2015
Last Update Posted: January 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Elena Pope, The Hospital for Sick Children
  Purpose
The purpose of this study is to assess the efficacy and safety of oral propranolol versus nadolol in patients with Infantile Hemangiomas (IH) in a randomized, controlled, double-blinded study.

Condition Intervention Phase
Infantile Hemangioma Drug: Nadolol Drug: Propranolol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nadolol Versus Propranolol in Children With Infantile Hemangiomas: a Randomized, Controlled, Double-blinded Trial

Resource links provided by NLM:


Further study details as provided by Elena Pope, The Hospital for Sick Children:

Primary Outcome Measures:
  • The change in the bulk (size/extent) and color of the infantile hemangioma (IH)at Week 24 compared to baseline using Visual Analog Scale (VAS). [ Time Frame: 24 weeks ]
    A 100 mm visual analog scale will be used to quantify changes in the visible bulk (size/extent) and color of the lesion by comparing clinical photographs at 24 weeks versus baseline


Secondary Outcome Measures:
  • Percent change in IH bulk using VAS at 4, 12, 52 weeks [ Time Frame: 4, 12, 52 weeks ]
  • Time and dose to reach the 50%, 75% and 100% tumor shrinkage [ Time Frame: 52 weeks ]
  • Inter-rater reliability of the VAS scores [ Time Frame: 52 weeks ]
  • Percentage of patients achieving functional correction at Week 4, 12, 24, 52 [ Time Frame: 52 weeks ]
  • Percent change in the volumetric changes of hemangioma [ Time Frame: 24 and 52 weeks ]
    [(Length + Width)/2]3 X 0.07

  • Percentage of patients with residual changes (telangiectasias, discoloration, fibro-fatty changes, anetoderma) [ Time Frame: 52 weeks ]
  • Frequency of observed and reported adverse events [ Time Frame: 52 weeks ]

Estimated Enrollment: 80
Study Start Date: September 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nadolol group
40 study participants will take Nadolol (oral liquid suspension)
Drug: Nadolol

Patients will be administered twice-daily doses of medication as follows: since Day 0- 0.5 mg/kg/day ; since Day 7-1.0 mg/kg/day and since Day 14- 1.5 mg/kg/day. In all subsequent visits the dosage will be adjusted based on the current weight rather than the baseline weight to maintain 1.5 mg/kg/day. Or the dose may be escalated (by 0.5 mg/kg/day at any following study visit) up to 3 mg/kg/day based on the clinical response to maintain the dose that led to at least 75% reduction in the hemangioma size until Week 24, when unblinding happen. At Week 24 paticipants can start weaning by 10% per week or continue with the last dose, depending on the investigator's decision.

S/he will be monitored until Week 52.

Other Name: N/A (any brand )
Active Comparator: Propranolol group
40 study paticipants will take Propranolol (oral liquid suspension)
Drug: Propranolol

Patients will be administered twice-daily doses of medication as follows: since Day 0- 0.5 mg/kg/day ; since Day 7-1.0 mg/kg/day and since Day 14- 1.5 mg/kg/day.

In all subsequent visits the dosage will be adjusted based on the current weight rather than the baseline weight to maintain 1.5 mg/kg/day. Or the dose may be increased by investigator, based on clinical response by 0.5 mg/kg/day at any study visit (up to 3 mg/kg/day divided twice a day) to maintain the dose that lead to at least 75% reduction in the hemangioma size until Week 24, when unblinding happen. At Week 24 paticipants can start weaning by 10% per week or continue with the last dose, depending on the investigator's decision.

S/he will be monitored until Week 52.

Other Name: N/A (any brand)

Detailed Description:
The study objective is to compare the efficacy and safety of oral propranolol in comparison with oral nadolol in patients with IH. Patients will be randomly assigned to either propranolol or dose equivalent nadolol. The duration of the study will be 24 weeks, however, patient will be monitored for up to 1 year post study enrolment. Both efficacy and safety will be closely monitored and captured.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1-6 months corrected age
  • Written parental informed consent
  • At least one of the following:

    • Size: hemangioma >1.5 cm on the face or >3 cm on other body parts
    • Causing or with potential for functional impairment (e.g. amblyogenic IH, ulcerated hemangioma)
    • Causing or with potential for cosmetic disfigurement (e.g. nasal tip, glabella location)

Exclusion Criteria:

  • Contraindications to beta-blockers

    • Hypotension
    • Bradycardia
    • Hypoglycemia
    • Cardiac disease associated with decreased ejection fraction and/or > second degree heart block
    • Bronchospasm (including bronchial asthma)
    • Allergic rhinitis
  • Corrected gestational age less than 1 month at screening
  • Patients with PHACES cerebral arteriopathy at risk of stroke
  • Patients and/or breastfeeding mothers receiving treatment with anti-arrhythmic agents, calcium channel blockers, ACE inhibitors, inotropic agents, vasodilators, hypoglycemic agents, neuroleptics, antiacids, benzodiazepines, thyroxine, warfarin
  • Patients treated with an oral beta-blocker or other agent (e.g. systemic steroids, vincristine) within 2 weeks from randomization
  • Patients treated with topical timolol within 1 week from randomization
  • Vascular tumors other than infantile hemangioma (e.g. pyogenic granuloma, hemangioendothelioma)
  Contacts and Locations
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): NCT02505971


Contacts
Contact: Elena Pope, MD, MSc 416-813-6883 elena.pope@sickkids.ca
Contact: Hanna Fadzeyeva, BSc 416-813-7835 hanna.fadzeyeva@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G1X8
Contact: Hanna Fadzeyeva    416-813-7835    Hfadzeyeva@sickkids.ca   
Contact: Elena Pope    416-813-6883    Epope@sickkids.ca   
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Elena Pope, MD, MSc The Hospital for Sick Children
  More Information

Responsible Party: Elena Pope, Section Head, Dermatology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02505971     History of Changes
Other Study ID Numbers: 1000048673
First Submitted: July 21, 2015
First Posted: July 22, 2015
Last Update Posted: January 5, 2016
Last Verified: January 2016

Keywords provided by Elena Pope, The Hospital for Sick Children:
hemangioma, propranolol, nadolol

Additional relevant MeSH terms:
Hemangioma
Hemangioma, Capillary
Port-Wine Stain
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Propranolol
Nadolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents