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
  Purpose

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.


Condition Intervention Phase
Oral Mucositis
Drug: Clonidine Lauriad® 50µg
Drug: Clonidine Lauriad® 100µg
Drug: Placebo Lauriad®
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by BioAlliance Pharma SA:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 183
Study Start Date: April 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clonidine Lauriad® 50µg
50µg muco-adhesive buccal tablets, once de day, every day up to 8 weeks
Drug: Clonidine Lauriad® 50µg
50µg muco-adhesive buccal tablet once day every day up to 8 weeks
Active Comparator: Clonidine Lauriad® 100µg
100µg muco-adhesive buccal tablets, once a 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
Placebo Comparator: Placebo Lauriad®
Placebo 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385748

Contacts
Contact: René-Jean Bensadoun, MD +33(0)5.49.44.44.93 rene-jean.bensadoun@chu-poitiers.fr

  Show 57 Study Locations
Sponsors and Collaborators
BioAlliance Pharma SA
Investigators
Study Director: Bérangère Vasseur, MD BioAlliance Pharma
  More Information

No publications provided

Responsible Party: BioAlliance Pharma SA
ClinicalTrials.gov Identifier: NCT01385748     History of Changes
Other Study ID Numbers: BA2009/28/01
Study First Received: June 29, 2011
Last Updated: April 29, 2014
Health Authority: France: ANSM - Agence nationale de sécurité du médicament
France: Institutional Ethical Committee
Spain: Ethics Committee
Spain: Spanish Agency of Medicines
United States: Food and Drug Administration
United States: Institutional Review Board
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Hungary: Research Ethics Medical Committee
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Switzerland: Swissmedic
Switzerland: Ethikkommission

Additional relevant MeSH terms:
Mucositis
Stomatitis
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Mouth Diseases
Stomatognathic Diseases
Clonidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sympatholytics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014