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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by BioAlliance Pharma SA
Sponsor:
Information provided by (Responsible Party):
BioAlliance Pharma SA
ClinicalTrials.gov Identifier:
NCT01385748
First received: June 29, 2011
Last updated: April 29, 2014
Last verified: April 2014

June 29, 2011
April 29, 2014
April 2010
December 2014   (final data collection date for primary outcome measure)
Percentage of patients with an oral mucositis score≥ 3 using the WHO scale at cumulative radiation dose of 50 Gy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Comparison between groups of the percentage of patients with an oral mucositis score ≥ 3 using the WHO scale at cumulative radiation dose of 50 Gy.
Same as current
Complete list of historical versions of study NCT01385748 on ClinicalTrials.gov Archive Site
Percentage of patients with an oral mucositis score≥ 3 using the WHO scale at cumulative radiation doses of 40 Gy and 60 Gy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Oral Mucositis
  • 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
  • Active Comparator: Clonidine Lauriad® 50µg
    50µg muco-adhesive buccal tablets, once de day, every day up to 8 weeks
    Intervention: Drug: Clonidine Lauriad® 50µg
  • Active Comparator: Clonidine Lauriad® 100µg
    100µg muco-adhesive buccal tablets, once a day, every day up to 8 weeks
    Intervention: Drug: Clonidine Lauriad® 100µg
  • Placebo Comparator: Placebo Lauriad®
    Placebo muco-adhesive buccal tablets, once a day, every day up to 8 weeks
    Intervention: Drug: Placebo Lauriad®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
183
June 2015
December 2014   (final data collection date for primary outcome measure)

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 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.
  • 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 AST and 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 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 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
Both
18 Years and older
No
Contact: René-Jean Bensadoun, MD +33(0)5.49.44.44.93 rene-jean.bensadoun@chu-poitiers.fr
United States,   France,   Germany,   Hungary,   Spain,   Switzerland
 
NCT01385748
BA2009/28/01
No
BioAlliance Pharma SA
BioAlliance Pharma SA
Not Provided
Study Director: Bérangère Vasseur, MD BioAlliance Pharma
BioAlliance Pharma SA
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP