NCT01385748

Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis

A Phase II, Multi-center, Randomised, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Clonidine Lauriad® 50 μg and 100 μg Mucoadhesive Buccal Tablet (MBT) Applied Once Daily to Those of Placebo in the Prevention and Treatment of Chemoradiation Therapy Induced Oral Mucositis in Patients With Head and Neck Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Valerio Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oral Mucositis

Interventions

Type	Name	Description
DRUG	Clonidine Lauriad® 50µg	50µg muco-adhesive buccal tablet once day every day up to 8 weeks
DRUG	Clonidine Lauriad® 100µg	100µg muco-adhesive buccal tablets, once a day, every day up to 8 weeks
DRUG	Placebo Lauriad®	placebo muco-adhesive buccal tablets, once a day, every day up to 8 weeks

Timeline

• Start date: 2010-04-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2011-06-30
• Last updated: 2017-11-28
• Results posted: 2017-08-09

Locations

51 sites across 6 countries: United States, France, Germany, Hungary, Spain, Switzerland