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Nadolol Versus Propranolol in Children With Infantile Hemangiomas

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ClinicalTrials.gov Identifier: NCT02505971
Recruitment Status : Recruiting
First Posted : July 22, 2015
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Elena Pope, The Hospital for Sick Children

July 21, 2015
July 22, 2015
May 1, 2018
September 2015
December 2018   (Final data collection date for primary outcome measure)
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
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
Complete list of historical versions of study NCT02505971 on ClinicalTrials.gov Archive Site
  • 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
  • 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 ]
Not Provided
Not Provided
 
Nadolol Versus Propranolol in Children With Infantile Hemangiomas
Nadolol Versus Propranolol in Children With Infantile Hemangiomas: a Randomized, Controlled, Double-blinded Trial
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Infantile Hemangioma
  • 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)
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
Same as current
December 2018
December 2018   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
1 Month to 6 Months   (Child)
No
Contact: Elena Pope, MD, MSc 416-813-6883 elena.pope@sickkids.ca
Contact: Hanna Fadzeyeva, BSc 416-813-7835 hanna.fadzeyeva@sickkids.ca
Canada
 
 
NCT02505971
1000048673
No
Not Provided
Not Provided
Elena Pope, The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Elena Pope, MD, MSc The Hospital for Sick Children
The Hospital for Sick Children
April 2018

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