Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation Therapy
NCT00790322 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2010-02-19
Summary
The purpose of this study is to evaluate the efficacy and safety of SBG vs placebo on oral mucositis in head and neck cancer patients undergoing radiation therapy.
Conditions
- Head and Neck Cancer
- Oral Mucositis
Interventions
- DRUG
-
SBG
Soluble beta-1,3/1,6-glucan is a solution for oral use
- OTHER
-
Placebo
Solution for oral use
Sponsors & Collaborators
-
Biotec Pharmacon ASA
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-10-31
- Primary Completion
- 2010-02-28
- Completion
- 2010-02-28
Countries
- France
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