ter in die (TID)three times a day for Infantile Hemangiomas

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
The University of Texas Health Science Center at Houston, Houston, TX
Infantile Hemangiomas+3 More
Propranolol three times a day - Drug
Eligibility
< 18
All Sexes
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Study Summary

The purpose of this study is to assess the baseline sleep pattern disruption for patients starting oral propranolol at the standard BID dosing regimen compared to the control (timolol) group and to determine if there is a significant improvement in the sleep patterns in infants taking oral propranolol on the TID dosing regimen versus the control (timolol) group

Eligible Conditions

  • Infantile Hemangiomas

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Infantile Hemangiomas

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 18 months from baseline

18 months from baseline
Amount of time it takes for subject to fall asleep
Clinical Response to Medication as assessed by the qualitative clinical assessment on size, color changes of hemangiomas
Longest stretch of time the subject is asleep without waking up
Number of participants with side effects
Qualitative assessment of difficulty falling asleep as assessed by the Brief Infant Sleep Questionnaire(BISQ)
Total amount of time subject is awake at night
6 months from baseline
Number of sleep awakenings per night as assessed by the Brief Infant Sleep Questionnaire(BISQ)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Infantile Hemangiomas

Trial Design

3 Treatment Groups

Control
1 of 3
ter in die (TID)three times a day
1 of 3
bis in die (BID)twice a day
1 of 3
Active Control
Experimental Treatment

174 Total Participants · 3 Treatment Groups

Primary Treatment: ter in die (TID)three times a day · No Placebo Group · Phase 4

ter in die (TID)three times a day
Drug
Experimental Group · 1 Intervention: Propranolol three times a day · Intervention Types: Drug
bis in die (BID)twice a day
Drug
Experimental Group · 1 Intervention: Propranolol twice a day · Intervention Types: Drug
Control
Drug
ActiveComparator Group · 1 Intervention: Timolol · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months from baseline

Trial Background

Prof. Matthew Greives, Associate Professor
Principal Investigator
The University of Texas Health Science Center, Houston
Closest Location: The University of Texas Health Science Center at Houston · Houston, TX
Photo of Houston  1Photo of Houston  2Photo of Houston  3
2008First Recorded Clinical Trial
1 TrialsResearching Infantile Hemangiomas
190 CompletedClinical Trials

Eligibility Criteria

Age < 18 · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.