Trials / Completed
CompletedNCT03932292
Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis
Prospective Comparator Study to Evaluate the Efficacy and Tolerability of Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Bitop AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2018-12-18
- Primary completion
- 2019-10-30
- Completion
- 2019-11-05
- First posted
- 2019-04-30
- Last updated
- 2019-11-06
Locations
1 site across 1 country: Hungary
Source: ClinicalTrials.gov record NCT03932292. Inclusion in this directory is not an endorsement.