MedTrace Logo

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

NCT01385748 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2017-11-28

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

  • Valerio Therapeutics

    lead INDUSTRY

Principal Investigators

  • Bérangère Vasseur, MD · Valerio Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • United States
  • France
  • Germany
  • Hungary
  • Spain
  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01385748 on ClinicalTrials.gov