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



Status:Completed
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - Any
Updated:11/30/2017
Start Date:April 2010
End Date:December 2014

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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

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.


Inclusion Criteria:

- Male or female

- 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:

- Tumours of the lips, sinuses, salivary glands

- 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
We found this trial at
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Besançon, 25030
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Billings, Montana 59101
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Denver, Colorado 80210
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Detroit, Michigan 48201
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Duarte, California 91010
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Farmington, Connecticut 06030
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Hershey, Pennsylvania 17033
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Miami, Florida 33145
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Riverside, California 92501
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Saint Louis, Missouri 63110
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Santa Maria, California
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Sun City, Arizona 85251
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The Bronx, New York 10467
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