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    Summary
    EudraCT Number:2009-014870-16
    Sponsor's Protocol Code Number:BA2009-28-01
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-19
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2009-014870-16
    A.3Full title of the trial
    A phase II, multicentre, randomized, 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 in patients to those of placebo in the prevention and treatment of chemoradion therapy-induced oral mucositis in patients with head and neck cancer
    A.4.1Sponsor's protocol code numberBA2009-28-01
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBioAlliance Pharma
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameClonidine Lauriad
    D.3.2Product code BA028
    D.3.4Pharmaceutical form Muco-adhesive buccal tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPGingival use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLONIDINE
    D.3.9.1CAS number 4205907
    D.3.9.2Current sponsor codeBA028
    D.3.9.3Other descriptive nameClonidine Lauriad
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameClonidine Lauriad
    D.3.2Product code BA028
    D.3.4Pharmaceutical form Muco-adhesive buccal tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPGingival use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLONIDINE
    D.3.9.1CAS number 4205907
    D.3.9.2Current sponsor codeBA028
    D.3.9.3Other descriptive nameClonidine Lauriad
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboMuco-adhesive buccal tablet
    D.8.4Route of administration of the placeboGingival use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention and treatment of chemoradion therapy-induced oral mucositis.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of Clonidine Lauriad® 50 μg and 100 μg mucoadhesive buccal tablet versus placebo in the prevention and treatment of chemoradiotherapy induced oral mucositis.
    E.2.2Secondary objectives of the trial
    - To determine the optimal dose of clonidine Lauriad® mucoadhesive buccal tablet
    - To determine the plasma and salivary pharmacokinetic parameters of Clonidine Lauriad® 50 μg and 100 μg mucoadhesive buccal tablet
    - To evaluate the quality of life of cancer patients treated with Clonidine Lauriad® MBT during radiochemotherapy
    - To evaluate the duration of mucoadhesive buccal tabletadhesion.
    - To evaluate the local and overall safety of Clonidine Lauriad® mucoadhesive buccal tablet
    - To preliminary evaluate the health economics in patients undergoing chemoradiotherapy treated with Clonidine Lauriad® mucoadhesive buccal tabletand placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female
    2. Aged >18 years
    3. Suffering from a newly diagnosed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx histologically-confirmed and having undergone resective surgery
    4. eligible to receive:
    a. a continuous course of conventional external beam irradiation (IRMT eligible) with a minimum cumulative radiation dose of 50 Gy and a maximum of 70 Gy, based on a daily dosing between 1.8 and 2.2 Gy. Planned radiation treatment fields must include at least two oral tissue sites (among buccal mucosa, floor of the mouth, tongue, soft palate) with each site receiving a total of 50 Gy or a maximum of 70 Gy.
    b. Chemotherapy consisting of standard dosing of cisplatin or carboplatin administered in standard weekly or tri-weekly cycles
    5. Karnofsky performance scale > 60% or ECOG ≥ 2
    6. Screening laboratory tests
    a. Hemoglobin ≥ 10g/dL
    b. White blood count ≥ 3500 cells/mm3
    c. Absolute neutrophil counts ≥ 1500 cells/mm3
    d. Direct bilirubin ≤ 2 times Upper Limit of Normal (ULN)
    e. Serum AST and ALT ≤ 3 ULN
    f. Serum creatinine ≤ 2 mg/dL
    g. Serum or urine pregnancy test: Negative
    8. Women of child bearing potential must have effective contraception method (oral or device)
    7. Signed written informed consent
    E.4Principal exclusion criteria
    1. Head and neck tumours of the lips, sinuses, salivary glands, or unknown primary site
    2. Prior radiation of the head and neck area
    3. Prior chemotherapy
    4. Curative surgery within less than 2 weeks or more than 10 weeks prior to the initiation of RT-CT
    5. Presence of active infectious disease
    6. Presence of active oral infectious disease, including oropharyngeal candidiasis and/or orofacial herpes
    7. Presence of oral mucositis
    8. Known or suspected chronic viral diseases including HIV
    9. Recent stroke within the last 6 months
    10. Bradyarrhythmia (< 60 b/min), including sinus node dysfunction or AV nodal conduction block 2nd or 3rd degree.
    11. Severe renal insufficiency (creatinine blood level > 1.5ULN)
    12. Administration of any concomitant treatment likely to interfere with clonidine
    13. Ongoing heavy alcohol consumption (>100g alcohol/day)
    14. Known hypersensitivity to clonidine, history of allergy or intolerance to milk proteins or any other component of the product
    15. Presence of severe or uncontrolled depression
    16. Pregnant or breast-feeding women
    17. Inability to give informed consent or comply with study requirements
    18. Unable or unwilling to comply with follow-up visits
    19. Participation to a clinical trial within 30 days prior to randomization and during the entire duration of the study
    E.5 End points
    E.5.1Primary end point(s)
    comparison between groups of the:
    Percentage of patients with an oral mucositis score ≥ 3 at cumulative radiation dose 50 Gy evaluated using the WHO scale
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    From the first inclusion to the last visit of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state183
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 183
    F.4.2.2In the whole clinical trial 183
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not applicable
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-08-20
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