At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open-label, Parallel Group Investigation to Compare the Performance of Standard Of Care (SOC) and Episil® in Combination Versus SOC Alone on Oral Mucositis in Patients Receiving Conditioning Treatment for Hematopoietic Stem Cell Transplantation
In Brief
A clinical study evaluating episil(R) and Oral hygiene procedures for Oral Mucositis. Completed, enrolled 116 participants across 12 sites in 4 countries.
Detailed Summary
To compare the performance of standard of care (SOC) + episil® versus SOC alone on oral mucositis in patients receiving conditioning treatment for hematopoietic stem cell transplantation (HSCT). The primary variable will be the area under the curve (AUC) of oral mucositis scores defined by the World Health Organisation (WHO) oral toxicity scale assessed daily by the investigator over the 28-day study period.
Study Details
Timeline
Interventions
episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.
Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)