Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis
NCT ID: NCT01385748
Last Updated: 2017-11-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
183 participants
INTERVENTIONAL
2010-04-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Clonidine Lauriad® 50µg
50µg muco-adhesive buccal tablets, once de day, every day up to 8 weeks
Clonidine Lauriad® 50µg
50µg muco-adhesive buccal tablet once day every day up to 8 weeks
Clonidine Lauriad® 100µg
100µg muco-adhesive buccal tablets, once a day, every day up to 8 weeks
Clonidine Lauriad® 100µg
100µg muco-adhesive buccal tablets, once a day, every day up to 8 weeks
Placebo Lauriad®
Placebo muco-adhesive buccal tablets, once a day, every day up to 8 weeks
Placebo Lauriad®
placebo muco-adhesive buccal tablets, once a day, every day up to 8 weeks
Interventions
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Clonidine Lauriad® 50µg
50µg muco-adhesive buccal tablet once day every day up to 8 weeks
Clonidine Lauriad® 100µg
100µg muco-adhesive buccal tablets, once a day, every day up to 8 weeks
Placebo Lauriad®
placebo muco-adhesive buccal tablets, once a day, every day up to 8 weeks
Eligibility Criteria
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Inclusion Criteria
* Aged \> 18 years
* Suffering from a newly diagnosed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx histologically-confirmed and having undergone resective surgery
* Prior neoadjuvant chemotherapy allowed provided that, the patient did not experience a World Health Organization (WHO) grade \> 2 oral mucositis during the neoadjuvant therapy.
* Patient eligible to receive concurrent chemo-radiation defined as:
1. A continuous course of conventional external beam irradiation (IMRT eligible) with a minimum cumulative radiation dose of 50 Gy or a maximum of 70 Gy, based on a daily dosing between 1.8 and 2.2 Gy combined with platinum based chemotherapy on a weekly or tri-weekly cycles.
2. Planned radiation treatment fields must include at least two oral tissue sites (among right or left buccal mucosa, floor of mouth, tongue, right or left soft palate) with each site receiving a total of 50 Gy or a maximum of 70 Gy. The radiation treatment plan will be reviewed by a designated radiation oncologist.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* Screening laboratory tests:
1. Haemoglobin ≥ 10g/dL
2. Absolute neutrophil counts ≥ 1500 cells/mm3
3. Platelets ≥ 100.000/mm3
4. Conjugated bilirubin ≤ 2 times Upper Limit of Normal (ULN)
5. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 ULN
6. Negative serum pregnancy test
* Women of child bearing potential must have effective contraception method (oral or device)
* Signed written informed consent
Exclusion Criteria
* Prior radiation of the head and neck area
* Curative surgery less than 2 weeks or more than 15 weeks prior to the initiation of radiation therapy-chemotherapy (RT-CT)
* Presence of active infectious disease
* Presence of active oral infectious disease, including oropharyngeal candidiasis and/or orofacial herpes
* Presence of oral mucositis
* Known or suspected chronic viral diseases including HIV
* Systolic blood pressure \< 100 mmHg and/or Diastolic blood pressure \< 50 mmHg
* Recent stroke within the last 6 months
* Bradyarrhythmia (\<60 b/min), including sinus node dysfunction or atrioventricular (AV) nodal conduction block 2nd or 3rd degree
* Subjects with orthostatic hypotension, defined by a decrease of systolic BP and/or diastolic BP above 20 mmHg when the patient stands up
* Renal insufficiency (creatinine blood level \> 1.5ULN)
* Ongoing heavy alcohol consumption (\>100g alcohol/day)
* Administration of any concomitant treatment likely to interfere with clonidine
* Known hypersensitivity to clonidine, history of allergy or intolerance to milk proteins or any other component of the product
* Presence of severe or uncontrolled depression
* Pregnant or breast-feeding women
* Inability to give informed consent or comply with study requirements
* Unable or unwilling to comply with follow-up visits
* Participation to a clinical trial within 30 days prior to randomization and during the entire duration of the study
18 Years
ALL
No
Sponsors
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Valerio Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Bérangère Vasseur, MD
Role: STUDY_DIRECTOR
Valerio Therapeutics
Locations
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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
St 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
Évreux, , 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-Grégoire, , 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 im Breisgau, , Germany
Universitatsklinikum Leipzig
Leipzig, , Germany
Paracelsius- Klinik
Osnabrück, , 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
Málaga, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Hospital de Navarra
Pamplona, , Spain
Centre Hospitalier Universitaire
Lausanne, , Switzerland
Countries
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Other Identifiers
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BA2009/28/01
Identifier Type: -
Identifier Source: org_study_id