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Completed

NCT Number: NCT02505971

Nadolol Versus Propranolol in Children With Infantile Hemangiomas

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.

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Key information

Conditions

Infantile Hemangioma Hemangioma Hemangioma, Capillary Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue

Age range

1 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nadolol

Drug

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 names: N/A (any brand )

Propranolol

Drug

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 names: N/A (any brand)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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%.

  3. 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.

  4. 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

  5. Percent change in the volumetric changes of hemangioma

    Time frame: 24 and 52 weeks

    [(Length + Width)/2]3 X 0.07

  6. Percentage of patients with residual changes (telangiectasias, discoloration, fibro-fatty changes, anetoderma)

    Time frame: 52 weeks

    Percentage of patients with residual changes

  7. Frequency of observed and reported adverse events

    Time frame: 52 weeks

    Frequency of observed and reported adverse events

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Nadolol Versus Propranolol in Children With Infantile Hemangiomas: a Randomized, Controlled, Double-blinded Trial

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jul 22, 2015
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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