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Amlexanox Oral Rinse for Radiation-Induced Oral Mucositis
NCT01083875Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2000
- Countries
- 1
- Sponsor
- Access Pharmaceuticals
- Modality
- Small Molecules
- Drugs
- amlexanox
- Conditions
- oral mucositis (OM)
01
Overview
Phase 2, randomised, double-blind trial in oral mucositis (OM) comparing 0.5% amlexanox oral rinse with Vehicle (2 arms). Primary endpoint: Oral Mucositis Assessment Score at 7 weeks. Started Feb 2000; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
0.5% amlexanox oral rinse
0.5% amlexanox oral rinse used 6 times daily
Vehicle
Vehicle rinse (MuGard) used 6 times daily
03
Who it enrols
Adult patients with head and neck cancer scheduled for radiation therapy (>= 60 Gy) involving at least 40% of the oral mucosa, with KPS >= 60% and adequate organ function.
04
Endpoints
Primary
Oral Mucositis Assessment Score
Secondary
Mucositis-related oral pain
Adverse Events
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