At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 183 enrolled
Drug / intervention
Clonidine Lauriad® 50µg +2 moredrug
Likely dose
Clonidine Lauriad® 50µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Clonidine Lauriad® 50µg, Clonidine Lauriad® 100µg, and 1 other intervention for Oral Mucositis. Completed, enrolled 183 participants across 51 sites in 6 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOral Mucositis
CountriesFrance, Germany, Hungary, Spain, Switzerland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2010
First PostedJun 2011
Primary CompletionOct 2014
Study CompletionDec 2014
TodayJul 2026
First PostedJun 30, 2011
Enrollment StartApr 1, 2010
Primary CompletionOct 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 15.0 years ago
Interventions
Clonidine Lauriad® 50µgdrug
50µg muco-adhesive buccal tablet once day every day up to 8 weeks
Clonidine Lauriad® 100µgdrug
100µg muco-adhesive buccal tablets, once a day, every day up to 8 weeks
Placebo Lauriad®drug
placebo muco-adhesive buccal tablets, once a day, every day up to 8 weeks