Benzydamine Oromucosal Solution in Oral Mucositis (BOOM)
NCT05055726 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2022-11-16
Summary
The aim of the present study is to collect data on the feasibility of a preventative/therapeutic approach of radiation-induced oral mucositis with benzydamine oromucosal solution (mouthwash) in patients with head and neck cancer.
Conditions
- Radiation-Induced Mucositis
- Head and Neck Cancer
Interventions
- DRUG
-
Benzydamine Hydrochloride 0.15% w/v oromucosal solution
Benzydamine Hydrochloride 0.15% w/v oromucosal solution (mouthwash), Angelini Pharma S.p.A.
Sponsors & Collaborators
-
PPD Development, LP
collaborator INDUSTRY -
Aziende Chimiche Riunite Angelini Francesco S.p.A
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-06
- Primary Completion
- 2022-09-05
- Completion
- 2022-09-05
Countries
- Hungary
- Poland
Study Locations
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