Conditions: Oral Mucositis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 183
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Clonidine Lauriad® to treat chemoradiation therapy induced severe oral mucositis in patients with head and neck cancer.

Detailed description:

Arms:
arm 1: 50µg muco-adhesive buccal tablets, once de day, every day up to 8 weeks arm 2: 100µg muco-adhesive buccal tablets, once a day, every day up to 8 weeks arm 3: Placebo muco-adhesive buccal tablets, once a day, every day up to 8 weeks

Interventions: intervention 1: Clonidine Lauriad® 50µg intervention 2: Clonidine Lauriad® 100µg intervention 3: Placebo Lauriad®
Intervention descriptions: intervention 1: 50µg muco-adhesive buccal tablet once day every day up to 8 weeks intervention 2: 100µg muco-adhesive buccal tablets, once a day, every day up to 8 weeks intervention 3: placebo muco-adhesive buccal tablets, once a day, every day up to 8 weeks

Protocol document: