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Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis

NCT03932292 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2019-11-06

No results posted yet for this study

Summary

This prospective non-interventional comparator study is to collect data on the clinical effectiveness and compliance of Ectoin® Mouth Wash solution (EML03) and to proof superiority to a well-established medical device on the market in the prevention of radiation-induced mucositis. The study doesn´t intervene with routine treatment strategy.

Conditions

  • Oral Mucositis Due to Radiation

Interventions

DRUG

Ectoin Mouth Wash

According to medical prescription of the instruction for use under consideration (at least 4x1 ampoule (5ml) daily, rinsed in the mouth for at least 30 seconds)

DRUG

Supersaturated solution of calcium and phosphate ions

According to medical prescription of the instruction for use under consideration (4 times a day).

Sponsors & Collaborators

  • Bitop AG

    lead INDUSTRY

Principal Investigators

  • Andreas Bilstein, PhD · Bitop AG

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-18
Primary Completion
2019-10-30
Completion
2019-11-05

Countries

  • Hungary

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 NCT03932292 on ClinicalTrials.gov