drugset / Trial / NCT03932292

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

NCT03932292

Completed 52 enrolled Bitop AG
Non-randomizedParallel-groupOpen-labelOther

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ectoine Unknown 5 ml Oral
Comparator Supersaturated solution of calcium and phosphate ions Unknown Oral

Indications