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Brief Title: Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis
Official Title: 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
Study ID: NCT01385748
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
21st Century Oncology of Arizona, Sun City, Arizona, United States
Compassionate Cancer Care Medical Group, Corona, California, United States
City of Hope, Duarte, California, United States
California Cancer Associates for Researche and Excellence, Fresno, California, United States
Compassionate Cancer Care Medical Group, Riverside, California, United States
Central Coast Medical Oncology Corp., Santa Maria, California, United States
Centura Health Research Center, Denver, Colorado, United States
University of Connectcut Health Center, Farmington, Connecticut, United States
AMPM Research Clinic, Miami, Florida, United States
Barbara Ann Karmonos Cancer Hospital, Detroit, Michigan, United States
Washington University School of medecine, Saint Louis, Missouri, United States
Billings Clinic Montana, Billings, Montana, United States
Winthrop University Hospital, Mineola, New York, United States
Montefiore Medical Center, The Bronx, New York, United States
Carolinas Medical Center- Carolinas Health Care System, Charlotte, North Carolina, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Penn State Hershey Cancer Institut, Hershey, Pennsylvania, United States
Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Hospital Jean Minjoz, Besançon, , France
CHU Morvan, Brest, , France
Centre François Baclesse, Caen, , France
Clinique Pasteur, Evreux, , France
Centre Oscar Lambret, Lille, , France
Clinique Chénieux, Limoges, , France
Clinique Hartmann, Neuilly-sur-Seine, , France
CH Lyon Sud, Pierre-Bénite, , France
CHU La Milétrie, Poitiers, , France
CHP St gregoire, Saint gregoire, , France
Centre de Cancérologie Etienne-Dolet, Saint-Nazaire, , France
Hôpital Bretonneau, Tours, , France
Institut Gustave Roussy, Villejuif, , France
Universitatsklinikum Erlangen Strahlenklinik, Erlangen, , Germany
Universitatsklinikum Essen, Essen, , Germany
Universitatsklinikum Freiburg Klinik fur Strahlentherapie, Freiburg, , Germany
Universitatsklinikum Leipzig, Leipzig, , Germany
Paracelsius- Klinik, Osnabruck, , Germany
Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza, Kecskemét, Nyíri u. 38, Hungary
Jósa András Oktatókórház Egészségügyi Szolgáltató Nonprofit Kft., Nyíregyháza, Szent István út 68, Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Miskolc,, Szentpéteri kapu 72-76, Hungary
Szent Imre Kórház, Budapest, Tétényi út 12-16., Hungary
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Universitario de La princesa, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital 12 de octubre, Madrid, , Spain
Hospital Puerta de Hierro Majadahonda, Madrid, , Spain
Hospital Universitario Ramon y cajal, Madrid, , Spain
Hospital Carlos Haya, Malaga, , Spain
Hospital Virgen de la Victoria, Malaga, , Spain
Hospital de Navarra, Pamplona, , Spain
Centre Hospitalier Universitaire, Lausanne, , Switzerland
Name: Bérangère Vasseur, MD
Affiliation: Valerio Therapeutics
Role: STUDY_DIRECTOR