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Nadolol Versus Propranolol in Children With Infantile Hemangiomas

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02505971
Recruitment Status : Active, not recruiting
First Posted : July 22, 2015
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Elena Pope, The Hospital for Sick Children

Tracking Information
First Submitted Date  ICMJE July 21, 2015
First Posted Date  ICMJE July 22, 2015
Last Update Posted Date April 22, 2020
Study Start Date  ICMJE September 2015
Actual Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
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 (VAS) 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
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2015)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • Percent change in IH bulk using VAS at 4, 12, 52 weeks [ Time Frame: 4, 12, 52 weeks ]
    A 100 mm visual analog scale (VAS) will be used to quantify changes in the visible bulk (size/extent) of the lesion by comparing clinical photographs at weeks 4, 12, and 52 versus baseline
  • Time and dose to reach the 50%, 75% and 100% tumor shrinkage [ Time Frame: 52 weeks ]
    Time frame since the baseline and study medication dose, when patient's IH decreased in size by 50%, 75% and 100%.
  • Inter-rater reliability of the VAS scores [ Time Frame: 52 weeks ]
    Two raters will assess the changes in IH for each study patient ( each visit). We will compare these results to assess inter-rater reliability.
  • Percentage of patients achieving functional correction at Week 4, 12, 24, 52 [ Time Frame: 4,12,24,52 weeks ]
    Percentage of patients achieving functional correction at Week 4, 12, 24, 52
  • 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 ]
    Percentage of patients with residual changes
  • Frequency of observed and reported adverse events [ Time Frame: 52 weeks ]
    Frequency of observed and reported adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2015)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nadolol Versus Propranolol in Children With Infantile Hemangiomas
Official Title  ICMJE Nadolol Versus Propranolol in Children With Infantile Hemangiomas: a Randomized, Controlled, Double-blinded Trial
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Infantile Hemangioma
Intervention  ICMJE
  • 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 )
  • 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)
Study Arms  ICMJE
  • Active Comparator: Nadolol group
    40 study participants will take Nadolol (oral liquid suspension)
    Intervention: Drug: Nadolol
  • Active Comparator: Propranolol group
    40 study paticipants will take Propranolol (oral liquid suspension)
    Intervention: Drug: Propranolol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 21, 2020)
74
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2015)
80
Estimated Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 6 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02505971
Other Study ID Numbers  ICMJE 1000048673
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elena Pope, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elena Pope, MD, MSc The Hospital for Sick Children
PRS Account The Hospital for Sick Children
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP