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Bupivacaine lozenges for oral mucositis in head/neck cancer
NCT02252926Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2014
- Primary completion
- Dec 2015
- Countries
- 1
- Sponsor
- Copenhagen University Hospital - Hvidovre
- Modality
- Small Molecules
- Drugs
- bupivacaine
- Conditions
- oral mucositis (OM)
01
Overview
Phase 2, randomised, open-label trial of bupivacaine in oral mucositis (OM) (2 arms), sponsored by Copenhagen University Hospital - Hvidovre. Primary endpoint: Reduction of oral and pharyngeal pain measured on Visual Analogue Scale (VAS) at 7 days. Started Sep 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Bupivacaine lozenge
Up to eight 25 mg bupivacaine lozenges/day
Standard treatment
Standard pain treatment (lidocaine, morphine, etc.)
03
Who it enrols
Patients diagnosed with head/neck cancer starting radiotherapy, able to speak Danish, excluding those with hypersensitivity to amide anesthetics or breastfeeding women.
04
Endpoints
Primary
Reduction of oral and pharyngeal pain measured on Visual Analogue Scale (VAS)
Secondary
Duration of the effect of the lozenge
Effect of the bupivacaine lozenge
Peak plasma concentrations of bupivacaine
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