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A Comparative Investigation of Standard Of Care (SOC) and Episil® in Combination Versus SOC Alone on Oral Mucositis

NCT01684566 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2016-03-14

Study results available
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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.

Conditions

  • Oral Mucositis

Interventions

DEVICE

episil(R)

episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.

OTHER

Oral hygiene procedures

Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)

Sponsors & Collaborators

  • Camurus AB

    lead INDUSTRY

Principal Investigators

  • Karin Garming-Legert, DDS, PhD. · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Germany
  • Israel
  • Poland
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01684566 on ClinicalTrials.gov