Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00003459

Trial Description

start of 1:1-Block title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003459
  •   2012/05/05
  •   2011/06/29
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT01385748  (ClinicalTrials.gov)
  •   BA2009/28/01  (BioAlliance Pharma SA)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Oral Mucositis
  •   K12.3 -  Oral mucositis (ulcerative)
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: Clonidine Lauriad 50µg
  •   Drug: Clonidine Lauriad 100µg
  •   Drug: Placebo Lauriad
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist
  •   Placebo, Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Percentage of patients with an oral mucositis score≥ 3 using the WHO scale at cumulative radiation dose of 50 Gy; time frame: 8 weeks; 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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- 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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   United States
  •   France
  •   Germany
  •   Hungary
  •   Spain
  •   Switzerland
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2010/04/30
  •   183
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • BioAlliance Pharma SA
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • BioAlliance Pharma
    • Bérangère Vasseur, MD 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • René-Jean Bensadoun, MD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   17
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.